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:
August 14, 2013Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2
Hazard: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table
August 14, 2013Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1
Hazard: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table
August 14, 2013Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-
Hazard: A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table
April 3, 2013Medical DevicesFDA
Biomerieux Inc recalls bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine
Hazard: The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
April 3, 2013Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #
Hazard: There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
April 3, 2013Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2)
Hazard: There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
April 3, 2013Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2)
Hazard: There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
February 6, 2013Medical DevicesFDA
bioMerieux, Inc. recalls BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic mic
Hazard: BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to
Hazard: The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog n
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Itali
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, Germ
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, c
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, c
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazil
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slova
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romania
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portugue
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, c
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, cat
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog n
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
November 28, 2012Medical DevicesFDA
Biomerieux Inc recalls bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog
Hazard: The product may mislabel patient information on culture specimen bottles due to a software miscommunication.