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.

51–75 of 423

  • HighFDA (Devices)·Z-0812-2023·2023-01-11

    FDA Recalls ASTUTE Electronic Quality Control Device for Storage Condition Excursion

    Biomerieux Inc. is recalling ASTUTE electronic quality control devices due to temperature and time storage excursion that may compromise product performance in laboratory settings.

    Product
    ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0840-2023·2023-01-11

    Gene-Up Lysis Kit Recalled Due to Storage Condition Violations

    Biomerieux Inc is recalling Gene-Up Lysis Kit (Catalog 414057) because storage conditions were exceeded and product performance cannot be guaranteed. Nationwide distribution.

    Product
    GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2023·2023-01-11

    Listeria Detection Test Strips Recalled for Unreliable Performance

    Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.

    Product
    API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2023·2023-01-11

    ETEST Clinical Vancomycin Test Kits Recalled Due to Storage Damage

    Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.

    Product
    ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2023·2023-01-11

    VITEK 2 AST-GP67 Reagent Test Kit Recalled Due to Storage Condition Excursion

    Biomerieux Inc. is recalling VITEK 2 Antibiotic Susceptibility Test Kits (AST-GP67) due to storage temperature and time conditions exceeding acceptable limits, which cannot guarantee product performance.

    Product
    VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2023·2023-01-11

    VITEK 2 Antibiotic Susceptibility Test Kits Recalled Due to Storage Condition Failures

    Biomerieux Inc is recalling VITEK 2 Reagent AST-GN73 test kits nationwide because they were stored outside proper temperature and time ranges, potentially compromising test accuracy.

    Product
    VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2023·2023-01-11

    Clinical reagent recalled due to temperature and time excursion

    Biomerieux Inc is recalling VITEK MS CLINICAL REAGENT VITEK MS-CHCA due to temperature and time excursions that may prevent product performance guarantees. No illnesses reported.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2023·2023-01-11

    Nephrocheck Liquid Control Reagent Recall Due to Storage Condition Violation

    Biomerieux is recalling one batch of Nephrocheck Liquid Control Reagent because the product was stored outside proper temperature and time parameters, making performance unreliable.

    Product
    ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2023·2023-01-11

    VIDAS Listeria 60T Clinical Diagnostic Test Kit Recalled for Storage Failure

    Biomerieux recalls VIDAS Listeria 60T test kits (Batch 1009371140) distributed nationwide because storage conditions were exceeded and product performance cannot be guaranteed. Users should discontinue use and contact the manufacturer.

    Product
    VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2023·2023-01-11

    Medical Device Test Kit Recalled Due to Storage Temperature and Time Excursions

    Biomerieux Inc is recalling 14 units of the VITEK 2 REAGENT YST TEST KIT distributed nationwide because temperature and time excursions during storage may compromise the kit's performance.

    Product
    VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0838-2023·2023-01-11

    Medical device test kit recalled due to storage temperature and time excursion

    Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit after storage conditions exceeded specified ranges, preventing guaranteed product performance. The recall affects 34 units distributed nationwide.

    Product
    VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2023·2023-01-11

    ETEST Clinical Meropenem Susceptibility Test Recalled for Storage Condition Failure

    Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.

    Product
    ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2023·2023-01-11

    ETEST Clinical Erythromycin test plates recalled for storage temperature deviation

    Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates (batch 1009157090) distributed nationwide. Product performance cannot be guaranteed due to temperature and time storage conditions that exceeded specifications.

    Product
    ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2023·2023-01-11

    VITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance

    Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.

    Product
    VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2023·2023-01-11

    Medical Diagnostic Reagent Recalled Due to Storage Temperature Damage

    Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.

    Product
    PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2023·2023-01-11

    TEMPO Control Kit Reagents Recalled Due to Storage Temperature Excursion

    Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.

    Product
    TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2023·2023-01-11

    Clinical Diagnostic Device Recall: ETEST Rifampicin RI 32 Performance Degradation

    Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 clinical diagnostic strips because temperature and time storage parameters were exceeded, and product performance cannot be guaranteed.

    Product
    ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0855-2023·2023-01-11

    Medical Device Reagent Recalled for Temperature Storage Condition Failure

    Biomerieux Inc recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.

    Product
    GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2023·2023-01-11

    Diagnostic Test Kit Recalled Due to Exceeded Storage Conditions

    Biomerieux Inc is recalling API STAPH 25 diagnostic test kits because storage conditions exceeded safe temperature and time parameters. Product performance cannot be guaranteed for the affected batch.

    Product
    API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0849-2023·2023-01-11

    Microbiological susceptibility test strips recalled for temperature and time excursion

    Biomerieux Inc. is recalling ETEST Clinical Imipenem Relebactam test strips (Catalog 420927) distributed nationwide because the product experienced temperature and time excursions during storage. The manufacturer cannot guarantee the product's test performance.

    Product
    ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0800-2023·2023-01-11

    VIDAS Quality Control Product Recalled for Storage Condition Deviation

    Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T nationwide due to storage temperature and time deviations that prevent performance guarantee. Batch 1009351560 is affected.

    Product
    VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0864-2023·2023-01-11

    VIDAS HCG 60 Clinical Test Kits Recalled for Exceeded Storage Conditions

    Biomerieux Inc is recalling VIDAS HCG 60 test kits because storage conditions were exceeded, which cannot guarantee product performance. No illnesses or injuries have been reported.

    Product
    VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0872-2023·2023-01-11

    Biomerieux Culture Media Recalled Due to Temperature and Time Excursions

    Biomerieux Inc is recalling diagnostic culture media because temperature and time storage conditions exceeded acceptable specifications, which means product performance cannot be guaranteed.

    Product
    PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0802-2023·2023-01-11

    CHROMID MRSA Culture Medium Recalled for Storage Temperature Exceedance

    Biomerieux Inc is recalling PPM CLINICAL CHROMID MRSA 20 PLT diagnostic culture media (84 units) due to temperature and time exceedance during storage that may compromise product performance.

    Product
    PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
    Category
    Medical Device
    Distribution
    Distributed nationwide