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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Biomerieux Inc: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Agency Publication Date: January 4, 2023
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Affected Products

Product: VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341

UDI/DI 03573026131913, Batch Numbers: 2412101403, 2412103403, 2412103503, 2412106403

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342

UDI/DI 03573026131920, Batch Numbers: 2422281503, 2422288503

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343

UDI/DI 03573026131937, Batch Numbers: 2432261103

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345

UDI/DI 353026131951, Batch Numbers: 2392195203

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346

UDI/DI 03573026144357, Batch Numbers: 2452278203

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226

UDI/DI 03573026242060, Batch Numbers: 1322258403

Lot Numbers:
Numbers
Product: PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586

UDI/DI 03573026263140, Batch Numbers: 230438

Lot Numbers:
Numbers
Product: PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588

UDI/DI 03573026263164, Batch Numbers: 229478

Lot Numbers:
Numbers
Product: VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217

UDI/DI 03573026064518, Batch Numbers: 229478

Lot Numbers:
Numbers
Product: VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219

UDI/DI 03573026064532, Batch Numbers: 1009421810

Lot Numbers:
Numbers
Product: VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226

UDI/DI 03573026138585, Batch Numbers: 1009370850

Lot Numbers:
Numbers
Product: VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700

UDI/DI 03573026065850, Batch Numbers: 1009371140

Lot Numbers:
Numbers
Product: VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702

UDI/DI 03573026065874, Batch Numbers: 1009406530

Lot Numbers:
Numbers
Product: VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706

UDI/DI 03573026121631, Batch Numbers: 1009351560

Lot Numbers:
Numbers
Product: PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631

UDI/DI 03573026118969, Batch Numbers: 1009532350

Lot Numbers:
Numbers
Product: PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841

UDI/DI 03573026313111, Batch Numbers: 1009525720, 1009530050

Lot Numbers:
Numbers
Product: PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851

UDI/DI 03573026313128, Batch Numbers: 1009540400

Lot Numbers:
Numbers
Product: PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871

UDI/DI 03573026316969, Batch Numbers: 1009501430

Lot Numbers:
Numbers
Product: BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011

UDI/DI 03573026228194, Batch Numbers: 7112

Lot Numbers:
Numbers
Product: BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012

UDI/DI 03573026228200, Batch Numbers: 7190

Lot Numbers:
Numbers
Product: BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017

UDI/DI 03573026228255, Batch Numbers: 7240

Lot Numbers:
Numbers
Product: API VP1 VP2 REAGENTS, CATALOG 70422

UDI/DI 03573026099626, Batch Numbers: 1009393450

Lot Numbers:
Numbers
Product: API NIT1 NIT2 REAGENTS, CATALOG 70442

UDI/DI 03573026099671, Batch Numbers: 1009326520

Lot Numbers:
Numbers
Product: API JAMES 2AMP, CATALOG 70542

UDI/DI 03573026099893, Batch Numbers: 1009360510

Lot Numbers:
Numbers
Product: TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000

UDI/DI 03573026128142, Batch Numbers: 1009477900

Lot Numbers:
Numbers
Product: ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016

UDI/DI 03573026565541, Batch Numbers: 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, 21EQC0174I

Lot Numbers:
Numbers
Product: PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849

UDI/DI 03573026357849, Batch Numbers: 2117760, 2120100

Lot Numbers:
Numbers
Product: VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893

UDI/DI 03573026359096, Batch Numbers: 11111288BM

Lot Numbers:
Numbers
Product: VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071

UDI/DI 03573026362836, Batch Numbers: 1009391190, 1009434380, 1009472100

Lot Numbers:
Numbers
Product: VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072

UDI/DI 03573026362843, Batch Numbers: 1009346190

Lot Numbers:
Numbers
Product: ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218

UDI/DI 03573026376567, Batch Numbers: 1009209480

Lot Numbers:
Numbers
Product: ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240

UDI/DI 03573026376581, Batch Numbers: 1009190560

Lot Numbers:
Numbers
Product: ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252

UDI/DI 03573026376703, Batch Numbers: 1009311920

Lot Numbers:
Numbers
Product: ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262

UDI/DI 03573026376802, Batch Numbers: 1009477980

Lot Numbers:
Numbers
Product: ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302

UDI/DI 03573026377205, Batch Numbers: 1009444340

Lot Numbers:
Numbers
Product: ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331

UDI/DI 03573026377533, Batch Numbers: 1009491830

Lot Numbers:
Numbers
Product: ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333

UDI/DI 03573026377557, Batch Numbers: 1009157090

Lot Numbers:
Numbers
Product: ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333

UDI/DI 03573026377717, Batch Numbers: 1009172020

Lot Numbers:
Numbers
Product: ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373

UDI/DI 03573026377953, Batch Numbers: 1009371780

Lot Numbers:
Numbers
Product: ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392

UDI/DI 03573026378073, Batch Numbers: 1009240000

Lot Numbers:
Numbers
Product: ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401

UDI/DI 03573026378165, Batch Numbers: 03573026378165, 03573026378165

Lot Numbers:
Numbers
Product: ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407

UDI/DI 03573026378226, Batch Numbers: 1009434000

Lot Numbers:
Numbers
Product: ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449

UDI/DI 03573026378592, Batch Numbers: 1009190620

Lot Numbers:
Numbers
Product: ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478

UDI/DI 03573026378875, Batch Numbers: 1009434160

Lot Numbers:
Numbers
Product: ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486

UDI/DI 03573026378950, Batch Numbers: 1009432150

Lot Numbers:
Numbers
Product: BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690

UDI/DI 03573026381103, Batch Numbers: 7408

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400

UDI/DI 03573026398460, Batch Numbers: 5892256103

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401

UDI/DI 03573026398477, Batch Numbers: 5902225503, 5902279403

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404

UDI/DI 03573026398507, Batch Numbers: 5932237403

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436

UDI/DI 03573026399016, Batch Numbers: 5992201403, 5992253503

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437

UDI/DI 03573026399023, Batch Numbers: 6702239503

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438

UDI/DI 03573026399030, Batch Numbers: 6712257403

Lot Numbers:
Numbers
Product: PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012

UDI/DI 03573026409913 , Batch Numbers: 2147080

Lot Numbers:
Numbers
Product: GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057

UDI/DI 3573026387761, Batch Numbers: 1009334990

Lot Numbers:
Numbers
Product: ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445

UDI/DI 03573026418748, Batch Numbers: 1009420460

Lot Numbers:
Numbers
Product: PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524

UDI/DI 03573026420758, Batch Numbers: 1009550310

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670

UDI/DI 03573026437183, Batch Numbers: 2752252403

Lot Numbers:
Numbers
Product: PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049

UDI/DI 03573026466435, Batch Numbers: 1009462900

Lot Numbers:
Numbers
Product: PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014

UDI/DI 03573026493868, Batch Numbers: 1009498140

Lot Numbers:
Numbers
Product: ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046

UDI/DI 03573026494537, Batch Numbers: 1009384490

Lot Numbers:
Numbers
Product: PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751

UDI/DI 03573026505684, Batch Numbers: 1009534170

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915

UDI/DI 03573026552152, Batch Numbers: 5412237203

Lot Numbers:
Numbers
Product: ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927

UDI/DI 03573026551544, Batch Numbers: 1008988170

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051

UDI/DI 03573026553982, Batch Numbers: 2782225503

Lot Numbers:
Numbers
Product: ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553

UDI/DI 03573026560997, Batch Numbers: 1009288050

Lot Numbers:
Numbers
Product: ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560

UDI/DI 03573026560690, Batch Numbers: 1008848690

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982

UDI/DI 03573026565923, Batch Numbers: 6852245503

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102

UDI/DI 03573026608132, Batch Numbers: 6892251103

Lot Numbers:
Numbers
Product: GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105

UDI/DI 03573026608514, Batch Numbers: 1009407250

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416

UDI/DI 03573026618834, Batch Numbers: 412148504

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425

UDI/DI 03573026618940, Batch Numbers: 3122253113

Lot Numbers:
Numbers
Product: PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723

UDI/DI 03573026618018, Batch Numbers: 1009552660

Lot Numbers:
Numbers
Product: ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786

UDI/DI 03573026618766, Batch Numbers: 1009462290

Lot Numbers:
Numbers
Product: ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788

UDI/DI 03573026618780, Batch Numbers: 1009351550

Lot Numbers:
Numbers
Product: VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

UDI/DI 03573026620288, Batch Numbers: 8312243203

Lot Numbers:
Numbers
Product: ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013

UDI/DI 03573026565503, Batch Numbers: 22LCK0024G

Lot Numbers:
Numbers
Product: ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348

UDI/DI 03573026254681, Batch Numbers: 1009261260, Research use only

Lot Numbers:
Numbers
Product: VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01

UDI/DI 03573026156923, Batch Numbers: 1009527770

Lot Numbers:
Numbers
Product: VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01

UDI/DI 03573026156930, Batch Numbers: 1009483380

Lot Numbers:
Numbers
Product: VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01

UDI/DI 03573026156954, Batch Numbers: 1009375960

Lot Numbers:
Numbers
Product: VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01

UDI/DI 03573026161637, Batch Numbers: 1009378680

Lot Numbers:
Numbers
Product: VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01

UDI/DI 03573026223601, Batch Numbers: 1009301530

Lot Numbers:
Numbers
Product: DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01

UDI/DI 03661901000857, Batch Numbers: 3073090

Lot Numbers:
Numbers
Product: PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100

UDI/DI 03661901005531, Batch Numbers: 2134340

Lot Numbers:
Numbers
Product: PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR

UDI/DI 03573026319946, Batch Numbers: 1009524320

Lot Numbers:
Numbers
Product: PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI

UDI/DI 03573026319953, Batch Numbers: 1009389930

Lot Numbers:
Numbers
Product: PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040

UDI/DI 03573026320362, Batch Numbers: 1009527240

Lot Numbers:
Numbers
Product: PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065

UDI/DI 03573026320485, Batch Numbers: 1009527290

Lot Numbers:
Numbers
Product: PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR

UDI/DI 03573026320706, Batch Numbers: 1009497920

Lot Numbers:
Numbers
Product: PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035

UDI/DI 03573026321420, Batch Numbers: 1009564750

Lot Numbers:
Numbers
Product: API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210

UDI/DI 03573026048082, Batch Number 1009373680

Lot Numbers:
Number
Product: API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500

UDI/DI 03573026048259, Batch Number 1009395530

Lot Numbers:
Number
Product: API 20 E 25 STRIPS, CATALOG 20100

UDI/DI 03573026047818, Batch Number 1009226560

Lot Numbers:
Number
Product: API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

UDI/DI 03573026035587, Batch Number 1009418280

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91148
Status: Active
Manufacturer: Biomerieux Inc
Manufactured In: United States
Units Affected: 93 products (5 unit; 1 unit; 1 unit; 1 unit; 348 units; 144 units; 14 units; 1 unit; 13 units; 15 units; 10 units; 1 unit; 2 units; 5 units; 2 units; 10 units; 15 units; 12 units; 10 units; 84 units; 1 unit; 1 unit; 2 units; 2 units; 2 units; 1 unit; 1 unit; 1 unit; 2 units; 5 units; 4 units; 13 units; 46 units; 29 units; 2 units; 2 units; 2 units; 1 unit; 5 units; 5 units; 2 units; 2 units; 7 units; 3 units; 3 units; 2 units; 4 units; 7 units; 2 units; 30 units; 120 units; 64 units; 310 units; 15 units; 34 units; 1 unit; 2 units; 6 units; 6 units; 218 units; 8 units; 7 units; 8 units; 6 units; 39 units; 2 units; 26 units; 2 units; 6 units; 84 units; 187 units; 2 units; 64 units; 50 units; 74 units; 1 unit; 2 units; 58 units; 3 units; 1 unit; 4 units; 4 units; 6 units; 7 units; 47 units; 14 units; 10 units; 60 units; 20 units; 1 unit; 20 units; 12 units; 100 units)

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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.