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.

376–400 of 423

  • ModerateFDA (Devices)·Z-1920-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux Inc is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfacing with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall Due to Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three drugs are not updated correctly when interfaced with laboratory systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during a software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1908-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Interface Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during the software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes were not updated correctly during an upgrade, potentially affecting laboratory reporting.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DE. Part number: 414539. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1918-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 DA, SV. Part number: 414567. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1912-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2013·2013-04-03

    Biomerieux VITEK 2 Compact Computer System Recall for Patient Data Error

    Biomerieux Inc. is recalling VITEK 2 Compact computer systems because a software issue could link test results to the wrong patient.

    Product
    VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc7700 8-port, Cat. #W0447; (4) dc7700 8-port (refurbished), Cat. #W0447R; (5) dc7800, Cat.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0990-2013·2013-04-03

    Biomerieux VITEK 2 XL Computer System Recalled for Patient Data Linking Errors

    Biomerieux Inc. is recalling VITEK 2 XL computer systems equipped with specific Hewlett-Packard PCs due to a potential risk of linking test results to the wrong patient.

    Product
    VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2013·2013-04-03

    Biomerieux VITEK 2 60 Computer System Recalled for Data Linking Error

    Biomerieux Inc is recalling VITEK 2 60 computer systems due to a potential error that could link test results to the wrong patient.

    Product
    VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1013-2013·2013-04-03

    bioMerieux VITEK 2 Streptococcus Card Recalled for Incorrect Package Insert

    Biomerieux Inc is recalling VITEK 2 AST-ST01 Streptococcus Susceptibility Cards because the package insert did not list the correct limitations of use and performance requirements.

    Product
    bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0738-2013·2013-02-06

    bioMerieux Recalls BacT/ALERT SA Blood Culture Bottles with Uncured Sensors

    bioMerieux, Inc. is recalling BacT/ALERT SA Blood Culture Bottles because some units may contain uncured sensors, potentially affecting the detection of microorganisms.

    Product
    BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0430-2013·2012-11-28

    Biomerieux Recalls 0.9% Sodium Chloride Injections for VITEK 2 System Use

    Biomerieux Inc is recalling 0.9% Sodium Chloride Injections that were distributed as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.

    Product
    0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0324-2013·2012-11-28

    BioMerieux B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling B.40 software updates because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0315-2013·2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Mislabeling Risk

    BioMerieux is recalling 28 software updates for the 3D B.40 instrument due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0321-2013·2012-11-28

    BioMerieux 3D IND ZIP-ML Software Update Recalled for Mislabeling

    BioMerieux is recalling 288 units of the 3D IND ZIP-ML software update because a defect may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0312-2013·2012-11-28

    BioMerieux BTA3D Combo Software Recall for Patient Mislabeling

    BioMerieux is recalling 205 BTA3D Combo software kits worldwide due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0305-2013·2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 250 units of the 3D B.40 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0303-2013·2012-11-28

    BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 860 units of 3D B.40 software updates due to a defect that may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0309-2013·2012-11-28

    BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling

    BioMerieux is recalling 620 units of 3D B.40 software updates because a software error may mislabel patient information on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0318-2013·2012-11-28

    BioMerieux BacT/ALERT Control Module Recalled for Software Mislabeling

    BioMerieux is recalling BacT/ALERT Control Modules because a software issue may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0322-2013·2012-11-28

    BioMérieux 3D IND Software Update Recalled for Patient Mislabeling

    BioMérieux is recalling 20 kits of the 3D IND USB-ML 02 software update because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.

    Product
    bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
    Category
    Medical Device
    Distribution
    19 states