Biomerieux Recalls
431 recalls on record · October 17, 2012 to July 15, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
July 15, 2026Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620
Hazard: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
February 11, 2026Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem
Hazard: Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
October 8, 2025Medical DevicesFDA
bioMerieux, Inc. recalls VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system c
Hazard: Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
May 1, 2024Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984;
Hazard: Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
March 8, 2023Medical DevicesFDA
Biomerieux Inc recalls MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments
Hazard: For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
January 11, 2023Medical DevicesFDA
Biomerieux Inc recalls ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
Hazard: As the temperature and time out of range was exceeded, product performances cannot be guaranteed