The Recall Desk

Manufacturer

bioMerieux, Inc.

423 recalls in our database name bioMerieux, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
423
Critical
0
Severe
13
Most recent
2026-09-30

Of the 423 recalls from bioMerieux, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 13 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 423

  • HighFDA (Devices)·Z-3231-2026·2026-09-30

    Biomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage

    Biomerieux Inc is recalling VITEK 2 AST-N461 test kits due to card pouch damage that may cause false resistant results, potentially leading to less effective antibiotic treatments.

    Product
    VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2715-2026·2026-07-15

    VITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results

    Biomerieux Inc is recalling VITEK 2 AST-N447 TEST KIT (Lot 0853293604) distributed internationally due to potential false resistant carbapenem and/or cephalosporin results when pouch foil fractures are present.

    Product
    VITEK 2 AST-N447 TEST KIT Product reference 424620
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1236-2026·2026-02-11

    Susceptibility test cards recalled over false resistant antibiotic results

    bioMerieux is recalling 2,668,954 VITEK 2 Gram-negative Susceptibility Cards over a potential risk of quality control failures and false resistant antibiotic results.

    Product
    VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2025·2025-10-08

    Antimicrobial susceptibility test cards recalled over false colistin resistance results

    bioMerieux is recalling 235,269 VITEK 2 Gram-negative AST cards containing colistin formulation cs02n because they may give false resistant results for multi-drug-resistant organisms.

    Product
    VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1464-2024·2024-05-01

    VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk

    Biomerieux Inc is recalling VITEK 2 AST test kits due to ceftriaxone concentration errors that could produce false susceptible results in antimicrobial susceptibility testing.

    Product
    VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1201-2023·2023-03-08

    Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules

    Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.

    Product
    MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2023·2023-01-11

    Medical Diagnostic Device Recalled Due to Temperature and Time Excursions

    Biomerieux Inc. is recalling PPM LOMBARD diagnostic products due to storage temperature and time conditions being exceeded during distribution, which compromises the product's guaranteed performance.

    Product
    PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2023·2023-01-11

    VIDAS Salmonella Diagnostic Test Kits Recalled Due to Storage Damage

    Biomerieux Inc. is recalling 15 units of VIDAS VIDAS Salmonella 60T diagnostic test kits (Catalog 30702) because storage conditions exceeded acceptable temperature and time parameters. The affected test kits may not perform reliably.

    Product
    VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2023·2023-01-11

    ETEST Antibiotic Susceptibility Test Kit Recalled for Storage Degradation

    Biomerieux Inc recalled ETEST antibiotic susceptibility test kits from batch 1009384490 due to storage conditions exceeding safe temperature and time parameters, potentially affecting test accuracy.

    Product
    ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2023·2023-01-11

    PPM Lombard Phosphate Buffer Recall Due to Temperature Exposure

    Biomerieux Inc is recalling PPM Lombard Phosphate Buffer products due to temperature and time exposure during storage or transport that may have compromised product performance.

    Product
    PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0795-2023·2023-01-11

    VIDAS Varicel Zoster IGG 60T Recalled Due to Storage Condition Excursion

    Biomerieux Inc is recalling VIDAS Varicel Zoster IGG 60T (Catalog 30217, Batch 229478) due to storage temperature and time exceedance. The recalled units cannot be guaranteed to perform accurately.

    Product
    VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2023·2023-01-11

    Medical device diagnostic plates recalled for storage condition violations

    Biomerieux Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, preventing performance guarantees.

    Product
    PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2023·2023-01-11

    Biomerieux VIDAS Progesterone Tests Recalled for Storage Condition Failure

    Biomerieux is recalling VIDAS Progesterone 60 diagnostic tests (Batch 1009375960) nationwide due to storage temperature and time conditions being exceeded, preventing guaranteed product performance.

    Product
    VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0860-2023·2023-01-11

    ETEST Vancomycin Susceptibility Test Recalled Due to Storage Damage

    Biomerieux recalled ETEST vancomycin susceptibility tests after storage temperature and time excursions that may compromise product reliability and test accuracy.

    Product
    ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0875-2023·2023-01-11

    FDA Recalls PPM Lombard TSA Culture Medium Due to Storage Temperature Exceedance

    Biomerieux Inc. is recalling PPM Lombard culture medium because the product was exposed to temperature and time conditions outside specification, potentially affecting test performance.

    Product
    PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2023·2023-01-11

    ETEST Clinical Amoxicillin/Clavulanic Acid Test System Recalled Due to Storage Excursion

    Biomerieux Inc is recalling ETEST CLINICAL AMOXI/CLAV 2/1 XL test systems nationwide (batch 1009311920) due to temperature and time storage excursions that may affect product performance.

    Product
    ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2023·2023-01-11

    ETEST Meropenem antibiotic susceptibility test recalled due to storage excursion

    Biomerieux is recalling ETEST Meropenem diagnostic tests because units experienced temperature and time storage excursions that may affect test accuracy. Affected lot 1009462290 was distributed nationwide.

    Product
    ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2023·2023-01-11

    Biomerieux PPM Culture Plates Recalled for Storage Stability Issues

    Biomerieux Inc is recalling PPM INDUSTRY COMBOURG BACARA culture plates because they were exposed to improper storage temperatures and duration. Product performance cannot be guaranteed under these conditions.

    Product
    PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2023·2023-01-11

    API VP1 VP2 Medical Reagents Recalled for Storage Condition Failure

    Biomerieux Inc is recalling API VP1 VP2 reagents (Catalog 70422) nationwide because storage temperature and time limits were exceeded, preventing the manufacturer from guaranteeing product performance.

    Product
    API VP1 VP2 REAGENTS, CATALOG 70422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0787-2023·2023-01-11

    VITEK 2 Reagent GN Test Kit Recalled Due to Storage Condition Exceedance

    Biomerieux Inc. is recalling 348 units of VITEK 2 Reagent GN Test Kit due to temperature and time storage parameter exceedance that may affect diagnostic performance. No illnesses reported.

    Product
    VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2023·2023-01-11

    Medical Device Reagent Recall Due to Storage Condition Exceedance

    Biomerieux is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 reagent kits because temperature and time storage conditions were exceeded, preventing performance guarantees. Distributed nationwide, affected units should be removed from service.

    Product
    DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2023·2023-01-11

    FDA Recalls VITEK 2 Antibiotic Susceptibility Test Kits Due to Storage Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT AST-GN69 test kits nationwide due to temperature and time excursions during storage that may compromise product performance.

    Product
    VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2023·2023-01-11

    FDA Recalls VITEK 2 AST-GP75 Test Kits for Storage Condition Violations

    Biomerieux Inc recalled 218 units of VITEK 2 AST-GP75 diagnostic test kits due to storage temperature and time violations that compromise test reliability. Affected facilities should stop using the recalled kits.

    Product
    VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2023·2023-01-11

    API JAMES 2AMP Clinical Diagnostic Device Recall Due to Storage Condition Violations

    Biomerieux Inc is recalling API JAMES 2AMP clinical diagnostic devices due to improper temperature and time storage conditions that may affect product performance. Affected units nationwide should not be used.

    Product
    API JAMES 2AMP, CATALOG 70542
    Category
    Medical Device
    Distribution
    Distributed nationwide