Biomerieux Inc: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

Agency Publication Date: May 22, 2017

Affected Products

Product: VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.

241396010 17/Oct/17 241398120 07/Nov/17 241398420 10/Nov/17 241398620 12/Nov/17 241398720 13/Nov/17 241398820 14/Nov/17 241399520 21/Nov/17 2410000203 26/Nov/17 2410002203 28/Nov/17 2410006203 02/Dec/17 2410007203 03/Dec/17 2410008203 04/Dec/17 2410009103 05/Dec/17 2410031103 27/Dec/17 2410033103 29/Dec/17 2410034103 30/Dec/17 2410037103 02/Jan/18 2410038103 03/Jan/18 2410041103 06/Jan/18 2410042103 07/Jan/18 2410043103 08/Jan/18 2410044203 09/Jan/18 2410047203 12/Jan/18 2410052103 17/Jan/18 2410057103 22/Jan/18 2410058103 23/Jan/18 2410063103 28/Jan/18 2410064103 29/Jan/18 2410065103 30/Jan/18 2410071103 05/Feb/18 2410072103 06/Feb/18 2410078103 12/Feb/18 2410083103 17/Feb/18 2410085203 19/Feb/18 2410086103 20/Feb/18 2410088103 22/Feb/18 2410091203 25/Feb/18 2410092103 26/Feb/18 2410093103 27/Feb/18 2410097103 03/Mar/18 2410098103 04/Mar/18 2410099103 05/Mar/18 2410100103 06/Mar/18 2410105203 11/Mar/18 2410106103 12/Mar/18 2410107203 13/Mar/18

Product: VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.

2420157103 02/May/18 2420164103 09/May/18 2420169103 14/May/18 2420174203 19/May/18 2420185103 30/May/18 2420198203 12/Jun/18 2420200103 14/Jun/18 2420204103 18/Jun/18 2420205103 19/Jun/18 2420220203 04/Jul/18 2420229203 13/Jul/18 2420239203 23/Jul/18 2420253203 06/Aug/18 2420267103 20/Aug/18 2420290103 12/Sep/18

Product: VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .

2430199103 13/Jun/18 2430199123 13/Jun/18

Product: VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.

2390150203 25/Apr/18

Product: VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton.

2450129203 04/Apr/18 2450162203 07/May/18 2450204203 18/Jun/18 2450221203 05/Jul/18 2450288203 10/Sep/18

Product: VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.

2440168103 13/May/18 2440202103 16/Jun/18 2440293203 15/Sep/18

Product: VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.

1060251103 04/Aug/18

Product: VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton.

1100152203 27/Apr/18 1100180103 25/May/18 1100201103 15/Jun/18 1100252203 05/Aug/18 1100258203 11/Aug/18 1100259203 12/Aug/18

Product: VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton.

1110249403 02/Aug/18

Product: VITEK¿ 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton.

2810176403 21/May/18

Product: VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.

1130069203 03/Feb/18 1130173203 18/May/18 1130192103 06/Jun/18 1130227203 11/Jul/18 1130266103 19/Aug/18

Product: VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton.

3570186103 31/May/18 3570242203 26/Jul/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.

1320165103 10/May/18 1320172103 17/May/18 1320172203 17/May/18 1320179203 24/May/18 1320186103 31/May/18 1320193103 07/Jun/18 1320194103 08/Jun/18 1320215103 29/Jun/18 1320215203 29/Jun/18 1320222103 06/Jul/18 1320223103 07/Jul/18 1320242103 26/Jul/18 1320242203 26/Jul/18 1320249103 02/Aug/18 1320250103 03/Aug/18 1320256103 09/Aug/18 1320256203 09/Aug/18 1320257103 10/Aug/18 1320263103 16/Aug/18 1320264103 17/Aug/18 1320264203 17/Aug/18 1320277103 30/Aug/18 1320277203 30/Aug/18 1320284103 06/Sep/18 1320284203 06/Sep/18 1320285103 07/Sep/18 1320285203 07/Sep/18 1320291103 13/Sep/18 1320291203 13/Sep/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP68), REF 22231, 20 cards per carton.

1330124203 30/Mar/18 1330187403 01/Jun/18 1330199203 13/Jun/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards per carton.

3600222203 06/Jul/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P584), REF 22252, 20 cards per carton.

4120244203 28/Jul/18

Product: VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton.

3640187403 01/Jun/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P586), REF 22276, 20 cards per carton.

3660165203 10/May/18 3660256103 09/Aug/18 3660284203 06/Sep/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P592), REF 22287, 20 cards per carton.

3720223103 07/Jul/18 3720250103 03/Aug/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P597), REF 22298, 20 cards per carton.

3770193203 07/Jun/18 3770287103 09/Sep/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP69), REF 22304, 20 cards per carton.

1340263203 16/Aug/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.

4800137203 12/Apr/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards per carton.

4830130203 05/Apr/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P605), REF 22325 20 cards per carton.

4850193203 07/Jun/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards per carton.

4860165103 10/May/18 4860228203 12/Jul/18

Product: VITEK 2 Gram Negative Susceptibility card (AST-GN38), REF 22331, 20 cards per carton.

4080143203 18/Apr/18 4080271103 24/Aug/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton.

4870131203 06/Apr/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton.

4880179203 24/May/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton.

4920179103 24/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per carton.

3130227403 11/Jul/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P613), REF 410027, 20 cards per carton.

4930186403 31/May/18

Product: VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.

5400115203 21/Mar/18 5400122223 28/Mar/18 5400136203 11/Apr/18 5400136223 11/Apr/18 5400136243 11/Apr/18 5400143203 18/Apr/18 5400192203 06/Jun/18 5400192223 06/Jun/18 5400192243 06/Jun/18 5400199203 13/Jun/18 5400216203 30/Jun/18 5400221203 05/Jul/18 5400238203 22/Jul/18 5400238223 22/Jul/18 5400238243 22/Jul/18 5400262223 15/Aug/18 5400269203 22/Aug/18 5400276203 29/Aug/18 5400276213 29/Aug/18 5400283203 05/Sep/18 5400283213 05/Sep/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P616), REF 410223, 20 cards per carton.

4960178203 23/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-XN04), REF 410401, 20 cards per carton.

1370124203 30/Mar/18 1370145203 20/Apr/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP71), REF 410750, 20 cards per carton.

2710228103 12/Jul/18 2710264203 17/Aug/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P618), REF 410806, 20 cards per carton.

4980130203 05/Apr/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P619), REF 411944, 20 cards per carton.

4990237103 21/Jul/18

Product: VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.

2850108203 14/Mar/18 2850209403 23/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN48), REF 412090, 20 cards per carton.

4680209103 23/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.

4690028203 24/Dec/17 4690167103 12/May/18 4690168103 13/May/18 4690187103 01/Jun/18 4690197203 11/Jun/18 4690208103 22/Jun/18 4690224203 08/Jul/18 4690229103 13/Jul/18 4690230103 14/Jul/18 4690237103 21/Jul/18 4690254203 07/Aug/18 4690265203 18/Aug/18 4690272103 25/Aug/18 4690277203 30/Aug/18 4690287203 09/Sep/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P621), REF 412533, 20 cards per carton.

5310123203 29/Mar/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N190), REF 412548, 20 cards per carton.

5600137203 12/Apr/18 5600171103 16/May/18 5600238103 22/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N193), REF 412604, 20 cards per carton.

5630169203 14/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N194), REF 412605, 20 cards per carton.

5640244203 28/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per carton.

5850166103 11/May/18 5850217403 01/Jul/18 5850248103 01/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N195), REF412609, 20 cards per carton.

5650195203 09/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N201), REF 412862, 20 cards per carton.

571375320 23/Dec/17 5710177103 22/May/18 5710208203 22/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per carton.

572381520 23/Feb/18 5720185203 30/May/18 5720230203 14/Jul/18 5720254103 07/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N203), REF 412864, 20 cards per carton.

5730188403 02/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N204), REF 412865, 20 cards per carton. .

5740178103 23/May/18 5740237203 21/Jul/18 5740278103 31/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N209), REF 412938, 20 cards per carton.

5790148203 23/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N211), REF 413043, 20 cards per carton.

6110117203 23/Mar/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N212), REF 413061, 20 cards per carton.

6120195203 09/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N208), IVD, REF 413062, 20 cards per carton.

5780224103 08/Jul/18 5780255103 08/AUG/18 5780275103 28/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N213), REF 413063, 20 cards per carton.

6130262103 15/Aug/18 6130280203 02/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N214), REF 413064, 20 cards per carton.

6140171203 16/May/18 6140218403 02/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton.

6150143203 18/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N216), REF 413066, 20 cards per carton.

6160195203 09/Jun/18 6160269203 22/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N217), REF 413080, 20 cards per carton.

6170132203 07/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N222), REF 413083, 20 cards per carton.

6220063203 28/Jan/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N223), REF 413110, 20 cards per carton.

6230087203 21/Feb/18 6230152203 27/Apr/18 6230279203 01/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N231), REF 413115, 20 cards per carton.

6310176103 21/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N232), REF 413116, 20 cards per carton.

6320117203 23/Mar/18 6320125203 31/Mar/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N233), REF 413117, 20 cards per carton.

6330202103 16/Jun/18 6330225203 09/Jul/18 6330252203 05/Aug/18 6330273203 26/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N227), REF 413144, 20 cards per carton.

6270176403 21/May/18 6270185103 30/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N228), REF 413145, 20 cards per carton.

6280111203 17/Mar/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N230), REF 413147, 20 cards per carton.

6300132203 07/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N235), REF 413170, 20 cards per carton.

6350208203 22/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N236), REF 413171, 20 cards per carton.

6360174203 19/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N237), REF 413172, 20 cards per carton.

637384320 23/Mar/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N238), REF 413203, 20 cards per carton.

6380188103 02/Jun/18 6380273203 26/Aug/18 6380292203 14/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-XN05), REF 413230, 20 cards per carton.

1480204103 18/Jun/18 1480243203 27/Jul/18 1480248203 01/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N243), REF 413392, 20 cards per carton.

6430203203 17/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N244), REF 413393, 20 cards per carton.

6440188103 02/Jun/18 6440227103 11/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N245), REF 413394, 20 cards per carton.

6450144203 19/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N246), REF 413395, 20 cards per carton.

6460171103 16/May/18 6460218203 02/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN66), REF 413398, 20 cards per carton.

5860216103 30/Jun/18 5860251203 04/Aug/18 5860270103 23/Aug/18 5860286203 08/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN69), REF 413400, 20 cards per carton.

5890166203 11/May/18 5890175203 20/May/18 5890208103 22/Jun/18 5890229103 13/Jul/18 5890230103 14/Jul/18 5890250203 03/Aug/18 5890251203 04/Aug/18 5890257203 10/Aug/18 5890258203 11/Aug/18 5890259203 12/Aug/18 5890262103 15/Aug/18 5890265203 18/Aug/18 5890270103 23/Aug/18 5890278103 31/Aug/18 5890279103 01/Sep/18 5890286103 08/Sep/18 5890286203 08/Sep/18 5890292103 14/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN70), REF 413401, 20 cards per carton.

5900175203 20/May/18 5900243103 27/Jul/18 5900243123 27/Jul/18 5900272203 25/Aug/18 5900286103 08/Sep/18 5900292103 14/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN71), REF 413402, 20 cards per carton.

5910026203 22/Dec/17 5910280203 02/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN72), REF 413403, 20 cards per carton.

5920174103 19/May/18 5920269103 22/Aug/18 5920294203 16/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN73), REF 413404, 20 cards per carton.

5930173103 18/May/18 5930215103 29/Jun/18 5930270203 23/Aug/18 5930271203 24/Aug/18 5930279103 01/Sep/18 5930287103 09/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN84), REF 413410, 20 cards per carton.

6740247103 31/Jul/18 6740272203 25/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN75), REF 413432, 20 cards per carton.

5950201103 15/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN76), REF 413433, 20 cards per carton.

5960176103 21/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN77), REF 413434, 20 cards per carton.

5970239203 23/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN79), REF 413436, 20 cards per carton.

5990174103 19/May/18 5990238103 22/Jul/18 5990251103 04/Aug/18 5990267203 20/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per carton.

6700244103 28/Jul/18 6700279203 01/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN81), REF 413438, 20 cards per carton.

6710245103 29/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN82), REF 413439, 20 cards per carton.

6720204203 18/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN83), REF 413440, 20 cards per carton.

6730188203 02/Jun/18 6730244203 28/Jul/18 6730280203 02/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N249), REF 413572, 20 cards per carton.

6490132203 07/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N250), REF 413573, 20 cards per carton.

6500132203 07/Apr/18 6500189203 03/Jun/18 6500229203 13/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N253), REF 413722, 20 cards per carton.

6530208203 22/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N254), REF 413723, 20 cards per carton.

6540146203 21/Apr/18 6540252103 05/Aug/18 6540290203 12/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N255), REF 413724, 20 cards per carton.

6550167203 12/May/18 6550226203 10/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-P625), REF 413727, 20 cards per carton.

5350137203 12/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N263), REF 413755, 20 cards per carton.

6630177103 22/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N264), REF 413864, 20 cards per carton.

664385120 31/Mar/18 6640203103 17/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N265), REF 413865, 20 cards per carton.

6650188203 02Jun18 6650194203 08Jun18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N268), REF 413868, 20 cards per carton.

6680255203 08/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN74), REF 413941, 20 cards per carton.

5940153203 28/Apr/18 5940255203 08/Aug/18 5940292403 14/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN86), REF 413942, 20 cards per carton.

6760274103 27/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN87), REF 413943, 20 cards per carton.

6770115203 21/Mar/18 6770153203 28/Apr/18 6770163203 08/May/18 6770217203 01/Jul/18 6770253203 06/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-XN06), REF 413944, 20 cards per carton.

1490195103 09/Jun/18 1490224203 08/Jul/18 1490244103 28/Jul/18 1490267203 20/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N270), REF 414162, 20 cards per carton.

6900190203 04/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N271), REF 414163, 20 cards per carton.

6910146203 21/Apr/18 6910282103 04/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N272), REF 414164, 20 cards per carton.

6920160203 05/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N276), REF 414286, 20 cards per carton.

6960139203 14/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N275), REF 414313, 20 cards per carton.

6950139203 14/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N279), REF 414492, 20 cards per carton.

6990268203 21/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N281), REF 414532, 20 cards per carton.

7010066203 31/Jan/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P628), REF 414534, 20 cards per carton.

5380116203 22/Mar/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P629), REF 414576, 20 cards per carton.

5390130203 05/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N285), REF 414740, 20 cards per carton.

7050141203 16/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N286), REF 414778, 20 cards per carton.

7060205203 19/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN90), REF 414779, 20 cards per carton.

6800159203 04/May/18 6800187403 01/Jun/18 6800290403 12/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN91), REF 414780, 20 cards per carton.

6810153203 28/Apr/18 6810244203 28/Jul/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards per carton.

7310166103 11/May/18 7310187103 01/Jun/18 7310221103 05/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN92), IVD, REF 414963, 20 cards per carton.

6820124203 30/Mar/18

Product: VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton.

2870115203 21/Mar/18 2870125203 31/Mar/18 2870129203 04/Apr/18 2870129223 04/Apr/18 2870143203 18/Apr/18 2870150203 25/Apr/18 2870157203 02/May/18 2870209403 23/Jun/18 2870221203 05/JUL/18 2870235203 19/Jul/18 2870241203 25/Jul/18 2870241223 25/Jul/18 2870248403 01/Aug/18 2870276203 29/Aug/18 2870283103 05/Sep/18 2870283203 05/Sep/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP74), REF 414971, 20 cards per carton.

2740242403 26/Jul/18 2740263203 16/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN93), REF 414985, 20 cards per carton.

6830196203 10/Jun/18 6830245203 29/Jul/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P633), REF 414994, 20 cards per carton.

7330166203 11/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N290), REF 415058, 20 cards per carton.

7100188203 02/Jun/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P632), REF 415059, 20 cards per carton.

7320223203 07/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N292), REF 415063, 20 cards per carton.

7120144203 19/Apr/18 7120194203 08/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N293), REF 415369, 20 cards per carton.

7130162203 07/May/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP75), IVD, REF 415670, 20 cards per carton.

2750173203 18/May/18 2750179103 24/May/18 2750210203 24/Jun/18 2750222103 06/Jul/18 2750236103 20/Jul/18 2750236123 20/Jul/18 2750249103 02/Aug/18 2750277103 30/Aug/18 2750285103 07/Sep/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P634), IVD, REF 415671, 20 cards per carton.

7340290103 12/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 cards per carton.

7170138203 13/Apr/18 7170145203 20/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N298), IVD, REF 416004, 20 cards per carton.

7180142203 17/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N300), IVD, REF 416241, 20 cards per carton.

7200153203 28/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N301), IVD, REF 416274, 20 cards per carton.

7210155203 30/Apr/18 7210187403 01/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N303), IVD, REF 416590, 20 cards per carton.

7230188203 02/Jun/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P635), IVD, REF 416911, 20 cards per carton.

7350166103 11/May/18 7350291103 13/Sep/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N311), IVD, REF 416952, 20 cards per carton.

7510145203 20/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N314), IVD, REF 417027, 20 cards per carton.

7540145203 20/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N315), IVD, REF 417426, 20 cards per carton.

7550202403 16/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N317), IVD, REF 417558, 20 cards per carton.

7570216203 30/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N320), IVD, REF 418204, 20 cards per carton.

7600203103 17/Jun/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P638), IVD, REF 418423, 20 cards per carton.

7380186403 31/May/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-GP76), IVD, REF 418424, 20 cards per carton.

2760186403 31/May/18 2760241203 25/Jul/18 2760255203 08/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N322), IVD, REF 418489, 20 cards per carton.

7620160203 05/May/18 7620261103 14/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N325), IVD, REF 418513, 20 cards per carton.

7650146203 21/Apr/18 7650240103 24/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N327), IVD, REF 418515, 20 cards per carton.

7670148203 23/Apr/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P640), IVD, REF 418579, 20 cards per carton.

7400144203 19/Apr/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P641), IVD, REF 418590, 20 cards per carton.

7410131203 06/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 cards per carton.

7630139203 14/Apr/18 7630258103 11/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N324), IVD, REF 418603, 20 cards per carton.

7640180403 25/May/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P642), IVD, REF 418604, 20 cards per carton.

7420116203 22/Mar/18 7420123203 29/Mar/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N328), IVD, REF 418630, 20 cards per carton.

7680177403 22/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N329), IVD, REF 418631, 20 cards per carton.

7690205103 19/Jun/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P643), IVD, REF 418671, 20 cards per carton.

7430193203 07/Jun/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P644), IVD, REF 418673, 20 cards per carton.

7440193203 07/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N330), IVD, REF 418674, 20 cards per carton.

7700138203 13/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N331), IVD, REF 418675, 20 cards per carton.

7710138203 13/Apr/18 7710205203 19/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N334), IVD, REF 418984, 20 cards per carton.

7740260203 13/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N335), IVD, REF 418985, 20 cards per carton.

7750260203 13/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N339), IVD, REF 419341, 20 cards per carton.

7790208203 22/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N340), IVD, REF 419412, 20 cards per carton.

7800178103 23/May/18 7800196203 10/Jun/18 7800260203 13/Aug/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P645), IVD, REF 419602, 20 cards per carton.

7450130203 05/Apr/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards per carton.

7460116203 22/Mar/18 7460194203 08/Jun/18 7460236203 20/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N344), IVD, REF 420440, 20 cards per carton.

7840209103 23/Jun/18 7840245203 29/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N345), IVD, REF 420580, 20 cards per carton.

7850138203 13/Apr/18

Product: VITEK¿ 2 Fungal Susceptibility card (AST-YS08), IVD, REF 420739, 20 cards per carton.

2880150203 25/Apr/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N348), IVD, REF 420856, 20 cards per carton.

7880142203 17/Apr/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 cards per carton.

7480123203 29/Mar/18 7480236203 20/Jul/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P649), IVD, REF 420858, 20 cards per carton.

7490131203 06/Apr/18 7490200103 14/Jun/18 7490236203 20/Jul/18

Product: VITEK¿ 2 Streptococcus Susceptibility card (AST-ST02), IVD, REF 420915, 20 cards per carton.

5410122203 28/Mar/18 5410199203 13/Jun/18 5410263203 16/Aug/18 5410263223 16/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N350), IVD, REF 421037, 20 cards per carton.

7900118203 24/Mar/18 7900139203 14/Apr/18 7900259103 12/Aug/18

Product: VITEK¿ 2 Streptococcus Susceptibility card (AST-ST03), IVD, REF 421040, 20 cards per carton.

5420269203 22/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 cards per carton.

791383620 16/Mar/18 7910163203 08/May/18 7910246203 30/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N352), IVD, REF 421258, 20 cards per carton.

7920118203 24/Mar/18 7920164103 09/May/18 7920243403 27/Jul/18 7920272103 25/Aug/18

Product: VITEK¿ 2 Gram Positive Susceptibility card (AST-P650), IVD, REF 421296, 20 cards per carton.

8000103203 09/Mar/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 cards per carton.

7930118203 24/Mar/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N354), IVD, REF 421350, 20 cards per carton.

7940149203 24/Apr/18 7940194203 08/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 cards per carton.

7950149203 24/Apr/18 7950197203 11/Jun/18 7950243403 27/Jul/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N356), IVD, REF 421352, 20 cards per carton.

7960170103 15/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N358), IVD, REF 421441, 20 cards per carton.

7980156203 01/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per carton.

7970156203 01/May/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 cards per carton.

7990203103 17/Jun/18 7990278203 31/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N362), IVD, REF 421585, 20 cards per carton.

8120216203 30/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N363), IVD, REF 421692, 20 cards per carton.

8130264403 17/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N364), IVD, REF 421693, 20 cards per carton.

8140264403 17/Aug/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 cards per carton.

1010160203 05/May/18 1010209203 23/Jun/18

Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 cards per carton.

5870203203 17/Jun/18 5870265103 18/Aug/18 5870265123 18/Aug/18 5870293203 15/Sep/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77026

Status: Resolved

Manufacturer: Biomerieux Inc

Manufactured In: United States

Units Affected: 179 products (177,828 cartons; 70,261 cartons; 5192 cartons; 583 cartons; 4125 cartons; 6316 cartons; 3,197 cartons; 18,156 cartons; 0; 488 cartons; 9,817 cartons; 1,533 cartons; 75,502 cartons; 1,974 cartons; 2,390 cartons; 499 cartons; 978 cartons; 4,089 cartons; 3,384 cartons; 1,247 cartons; 315 cartons; 1,487 cartons; 1,051 cartons; 817 cartons; 824 cartons; 1,182 cartons; 1,232 cards; 3,387 cartons; 425 cartons; 490 cartons; 19,398 cartons; 2,260 cartons; 3124 cartons; 1972 cartons; 487 cartons; 2,181 cartons; 2251 cartons; 1,192 cartons; 32,628 cartons; 1,005 cartons; 9224 cartons; 1,592 cartons; 1,226 cartons; 5559 cartons; 6813 cartons; 2,239 cartons; 6275 cartons; 1,065 cartons; 568 cartons; 511 cartons; 4709 cartons; 3665 cartons; 3382 cartons; 536 cartons; 1181 cartons; 512 cartons; 2554 cartons; 5795 cartons; 2,564 cartons; 2,499 cartons; 10,774 cards; 968 cartons; 1,183 cartons; 1,216 cartons; 523 cartons; 1,965 cartons; 540 cartons; 7189 cartons; 1,186 cartons; 1,370 cartons; 3330 cartons; 524 cartons; 5048 cartons; 4810 cartons; 48,371 cartons; 18,361 cartons; 1,043 cartons; 5,146 cartons; 11,107 cartons; 2,187 cartons; 1,618 cartons; 2,342 cartons; 708 cartons; 7,717 cartons; 3,131 cartons; 859 cartons; 167 cartons; 1,040 cartons; 1,248 cartons; 5,182 cartons; 1,001 cartons; 4,012 cartons; 3,612 cartons; 468 cartons; 3,669 cartons; 1,533 cartons; 2,476 cartons; 977 cartons; 2,793 cartons; 281 cartons; 2,428 cartons; 8,417 cartons; 2,359 cartons; 3,624 cartons; 1,211 cartons; 477 cartons; 522 cartons; 2,340 cartons; 2,347 cartons; 1,221 cartons; 463 cartons; 500 cartons; 992 cartons; 1,468 cartons; 696 cartons; 6,320 cards; 997 cartons; 12,738 cartons; 417 cartons; 1,592 cartons; 498 cartons; 3,599 cartons; 948 cartons; 511 cartons; 24,158 cartons; 0 cartons; 1,029 cartons; 474 cartons; 493 cartons; 2,186 cartons; 501 cartons; 1,263 cartons; 617 cartons; 512 cartons; 552 cartons; 494 cartons; 2,458 cartons; 1,278 cartons; 2,541 cartons; 1,017 cartons; 1,017 cartons; 1,009 cartons; 3,172 cartons; 2,468 cartons; 492 cartons; 219 cartons; 498 cartons; 994 cartons; 1,505 cartons; 513 cartons; 505 cartons; 514 cartons; 10,935 cartons; 426 cartons; 1,490 cartons; 6,761 cartons; 500 cartons; 192 cartons; 511 cartons; 1,852 cartons; 1,449 cartons; 3,277 cartons; 4,574 cartons; 463 cartons; 8,270 cartons; 2,535 cartons; 599 cartons; 511 cartons; 1,026 cartons; 3,419 cartons; 474 cartons; 662 cartons; 524 cartons; 3,629 cartons; 500 cartons; 0 cartons; 0 cartons; 945 cartons; 12,799 cartons)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.