BioMerieux SA: Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Agency Publication Date: March 21, 2017

Affected Products

Product: ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine th

Reference no. 506758, Lot #1003693010, 003922720, 003945330, 004193850, 004325620, 004427220, 004510540, 1004720640 & 1004830190 and Reference no. 506718, Lot #1003788640, 1003823960, 1003945320, 1004427210, 1004510360, 1004719300 &1004830170.

Lot Numbers:

1003693010

1003788640

Product: ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine th

Reference no. 503558, Lot #1003158260 and Reference no. 503518, Lot #1003161140.

Lot Numbers:

1003158260

1003161140

Product: ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Min

Reference no. 412302, Lot #1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200 & 1004876830 and Reference no. 412303, Lot # 1002939450, 1003089900, 1003813690, 1003851120, 1003953500, 1004152070, 1004315690, 1004394520, 1004525320, 1002939450, 1003089900, 1004755940, 1004828440, 1004876840 & 1005118100.

Lot Numbers:

1002939460

1002939450

Product: Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the M

Reference no. 508650, Lot #1001060450, 1001154650, 1001212890, 1001264540, 1001319180, 1001390080, 1001390440, 1001409510, 1001409520, 1001441760, 1001540660, 1001589490, 1001621240 & 1001656460; Reference no. 508658, Lot #1001093880, 1001154820, 1001265110, 1001319480, 1001390570, 1001441910, 1001487610, 1001647880, 1001708510, 1001811360, 1002041010, 1002102920, 1002435570, 1002567240, 1002725010, 1003246020, 1003889730, 1004168400, 1004364330, 1004491220 & 1004939670; Reference no. 508610, Lot #1001026950, 1001199360 1001427690, 1001518090, 1001595490, 1001740320 & 1001989260 and Reference no. 508618, Lot #1001032350, 1001242030, 1001338050, 1001416820, 1001471720, 1001595500, 1001627650, 1001720440, 1001728140, 1001786480, 1001956220, 1002109250, 1002338880, 1002435190, 1002566960, 1002718380, 1002975330, 1003886270, 1003894060, 1003981160, 1004064990, 1004075190, 1004168390, 1004490810 & 1004939640.

Lot Numbers:

1001060450

1001093880

1001026950

1001032350

Product: ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the

Reference no. 525550, Lot #1001094650, 1001136230, 1001212920, 1001293800, 1001302920, 1001319720, 1001334090, 1001391310, 1001430030, 1001518060 & 1001686190; Reference no. 525558, Lot #1001174720, 1001251340, 1001334100, 1001368020, 1001442000, 1001566840, 1001647970, 1001734920, 1001761450, 1001761480, 1001897000, 1001898600, 1002008040, 1002073480, 1002197270, 1002282890, 1002338820, 1002365880, 1002443950, 1002465840, 1002558040, 1002562240, 1002733640, 1002751340, 1003171920, 1003449250, 1003679000, 1003836080, 1004040220, 1004121870, 1004151340, 1004173130, 1004256780, 1004264340, 1004371500, 1004491190, 1004509340, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320, 1005186480, 1004735790, 1004767430, 1004775900, 1004914010, 1004980280, 1005027180 & 1005132340; Reference no. 525510, Lot #1001051200, 1001125840, 1001416930, 1001455150, 1001548250 & 1001596090 and Reference no. 525518, Lot #1001192860, 1001223460, 1001317000, 1001338170, 1001416940, 1001416950, 1001492590, 1001566860, 1001634070, 1001728340, 1001761460, 1001887350, 1001894800, 1002007990, 1002045080, 1002113290, 1002197250, 1002287970, 1002338070, 1002369060, 1002440920, 1002463490, 1002496690, 1002565090, 1002583690, 1002604690, 1002663860, 1002809200, 1002809880, 1002876470, 1002922750, 1003079740, 1003134480, 1003373510, 1003621540, 1003778630, 1003809630, 1003910700, 1003972790, 1004052410, 1004121860, 1004150380, 1004256770, 1004371490, 1004496990, 1004508060, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320 & 1005186480.

Lot Numbers:

1001094650

1001174720

1001051200

1001192860

Product: ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the M

Reference no. 535958, Lot #1004265390 & 1005138210 and Reference no. 535918, Lot #1003902400, 1004103780, 1004266960, 1004867770.

Lot Numbers:

1004265390

1003902400

Product: ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is us

Reference no. 502558, Lot #1003036730, 1003142000, 1003191650, 1003408580, 1004047410, 1004139950, 1004242300, 1004539350, , 1004783810, 1004872380, 1004910650 & 1004985540 and Reference no. 502518, Lot #1002911350, 1002964350, 1003012790, 1004047370, 1004140000, 1004244180, 1004420440, 1004539950, 1004783760, 1004872350, 1004896600.

Lot Numbers:

1003036730

1002911350

Product: ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine

Reference no. 529140, Lot #1001390510, 1001441860, 1001609400, 1001733320, 1001761030, 1001920530, 1001966610, 1002009360, 1002084930, 1002106570, 1002158050, 1002168110, 1002395840, 1002452170, 1002500020, 1002604960, 1002992250, 1003030810, 1003127520, 1003274260, 1003322150, 1003412730, 1003535930, 1003678890, 1003800400, 1004100220, 1004177630, 1004365540, 1004410620, 1004557900, 1004703240, 1004783050, 1004838760, 1005034320, 1005097790, 1005151830; Reference no. 529148, Lot #1001368050, 1001442030, 1001566960, 1001578760, 1001708630, 1001833500, 1001894590, 1001920200, 1001955170, 1002084950, 1002172820, 1002226550, 1002410940, 1002451250, 1002501640, 1002604970, 1002964340, 1002992260, 1003121770, 1003274280, 1003491070, 1003526920, 1003626710, 1003743380, 1003946090, 1004037330, 1004273540, 1004323330, 1004557890, 1004593710, 1004696420, 1004790240, 1005031600, 1005098130, 1005151890 & 1005151920; Reference no. 529100, Lot #1001324170, 1001378120, 1001403920, 1001433710, 1001472010, 1001487340, 1001517680, 1001535750, 1001567600, 1001617880, 1001621170, 1001702730, 1001707190, 1001726300, 1001761020, 1001879240, 1001927370, 1001976740, 1001998470, 1002123080, 1002160660, 1002391350, 1002449230, 1002487920, 1002551790, 1002614480, 1002705810, 1002786510, 1002890670, 1002960380, 1002992220, 1003030800, 1003181900, 1003274090, 1003491050, 1003836110, 1004100080, 1004137920, 1004273550, 1004381380, 1004593700, 1004629890, 1004631880, 1004851860, 1005034300, 1005192380 & 1005261410 and Reference no. 529108, Lot #1001324180, 1001370190, 1001482570, 1001527650, 1001567610, 1001634260, 1001744620, 1001829580, 1002044710, 1002090510, 1002175950, 1002223920, 1002392160, 1002449900, 1002494590, 1002565460, 1002615530, 1002706050, 1002785800, 1002960400, 1002992240, 1003099530, 1003182230, 1003322130, 1003404520, 1003491000, 1003526910, 1003580860, 1003629820, 1003876820, 1004022140, 1004177620, 1004323320, 1004576570, 1004680780, 1004941770, 1005098120, 1005212770 & 1005302500.

Lot Numbers:

1001390510

1001368050

1001324170

1001324180

Product: ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimu

Reference no. 513610, Lot #1001125240 & 1001610770; Reference no. 513618, Lot #1001193130, 1001223300, 1001316710, 1001377740, 1001454060, 1001454090, 1001527340, 1001633670, 1001721100, 1001801280, 1001804930, 1002029820, 1002234950, 1002238110, 1002269280, 1002476170, 1002593870, 1002699130, 1002702380 & 1003066070; Reference no. 513658, Lot #1001154880, 1001265150, 1001368000, 1001390590, 1001487630, 1001609830, 1001676400, 1001735190, 1001811380, 1002056670, 1002230910, 1002478800, 1002596830 & 1003066090 and Reference no. 513650, Lot #1001135740, 1001154700, 1001251110, 1001319240, 1001333960, 1001409550, 1001557360, 1001574370.

Lot Numbers:

1001125240

1001193130

1001154880

1001135740

Product: ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine

Reference no. 512550, Lot # 1002001100 & 1002048740; Reference no. 512510, Lot #1001970170 & 1002154750; Reference no. 512558, Lot #1001564260, 1001676270, 1001733240, 1001793760, 1001873760, 1002113320, 1002230930, 1002559800, 1002823250, 1002113320, 1002230930, 1002559800, 1002823250, 1003495040, 1003883840, 1004248160, 1004252230, 1004277880, 1004567040, 1004946070, 1004980260, 1005146190, 1003495040, 1003883840, 1004248160, 1004252230, 1004277880, 1004567040, 1004946070, 1004980260 & 1005146190 and Reference no. 512518, Lot #1001595660, 1001707960, 1001803880, 1002094250, 1002229210, 1002233690, 1002559790, 1002684500, 1002823910, 1003164040, 1003191670, 1003279330, 1003604650, 1004047450, 1004157400, 1004247950, 1004252220, 1004528390 & 1004567000.

Lot Numbers:

1002001100

1001970170

1001564260

1001595660

Product: ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine

Reference no. 522718, Lot #1001761650, 1002112440, 1002860460 & 1005166530 and Reference no. 522758, Lot #1001888970, 1002281590 & 1003590490.

Lot Numbers:

1001761650

1001888970

Product: ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determin

Reference no. 507058, Lot #1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030 and Reference no. 507018, Lot #1002940880, 1003182290, 1003813700, 1003851130, 1003953490, 1004239880, 1004316460, 1004527210, 1004755930, 1004828450, 1004876850 & 1004919010.

Lot Numbers:

1002940890

1002940880

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76201

Status: Resolved

Manufacturer: BioMerieux SA

Manufactured In: France

Units Affected: 12 products (unknown; unknown; unknown; unknown; unknown; unknown; unknown; unknown; unknown; unknown; unknown; unknown)

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.

Affected Products

Lot Numbers:

1003693010

1003788640

Reference no. 503558, Lot #1003158260 and Reference no. 503518, Lot #1003161140.

Lot Numbers:

1003158260

1003161140

Lot Numbers:

1002939460

1002939450

Lot Numbers:

1001060450

1001093880

1001026950

1001032350

Lot Numbers:

1001094650

1001174720

1001051200

1001192860

Reference no. 535958, Lot #1004265390 & 1005138210 and Reference no. 535918, Lot #1003902400, 1004103780, 1004266960, 1004867770.

Lot Numbers:

1004265390

1003902400

Lot Numbers:

1003036730

1002911350

Lot Numbers:

1001390510

1001368050

1001324170

1001324180

Lot Numbers:

1001125240

1001193130

1001154880

1001135740

Lot Numbers:

1002001100

1001970170

1001564260

1001595660

Reference no. 522718, Lot #1001761650, 1002112440, 1002860460 & 1005166530 and Reference no. 522758, Lot #1001888970, 1002281590 & 1003590490.

Lot Numbers:

1001761650

1001888970

Lot Numbers:

1002940890

1002940880