The Recall Desk

Manufacturer

bioMerieux, Inc.

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

What the numbers show

Total
422
Critical
0
Severe
5
Most recent
2026-07-15

Of the 422 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 5 (1%) 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.

326–350 of 422

  • ModerateFDA (Devices)·Z-2508-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2428-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2372-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Streptococcus Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Streptococcus Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2353-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Container Integrity

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2344-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Bacillus Identification Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Bacillus identification cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2378-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Fungal Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Fungal Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2362-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation and loss of potency.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2364-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P605), REF 22325 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2349-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2519-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling 474 cartons of VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N356), IVD, REF 421352, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2385-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, leading to antibiotic degradation and loss of potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2402-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, risking antibiotic degradation and loss of potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N231), REF 413115, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2518-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2420-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN71), REF 413402, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2465-2017·2017-06-21

    Biomerieux VITEK 2 Gram Negative Susceptibility Card Recall

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards due to potential container integrity issues that may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N290), REF 415058, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphy
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1639-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1646-2016·2016-05-18

    Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards Recalled for Labeling Error

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1645-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1643-2016·2016-05-18

    Biomerieux Vitek 2 Gram Positive Test Cards Recalled for Labeling Error

    Biomerieux is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1644-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1640-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphyl
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1642-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1647-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylo
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1596-2016·2016-05-11

    bioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards

    bioMerieux is recalling VITEK 2 Gram Positive Susceptibility Test Cards because they may produce false susceptible results for specific bacteria to Minocycline.

    Product
    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibi
    Category
    Medical Device
    Distribution
    0 states