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:
December 23, 2015Medical DevicesFDA
bioMerieux, Inc. recalls MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology wh
Hazard: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
December 23, 2015Medical DevicesFDA
bioMerieux, Inc. recalls MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology
Hazard: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
December 23, 2015Medical DevicesFDA
bioMerieux, Inc. recalls MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technolo
Hazard: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
December 23, 2015Medical DevicesFDA
bioMerieux, Inc. recalls MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology
Hazard: MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
May 27, 2015Medical DevicesFDA
bioMerieux, Inc. recalls MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer appl
Hazard: The MYLA¿ server could slow down due to the volume ( weight ) of the data to manage and it could also stop processing, impacting the server start-up phase. The problem occurs in high volume settings. The MYLA server slows down and will stop processing completely if any task requires more than 5 minutes to complete. The server then fails to reboot and requires service, provided remotely or on-site
May 20, 2015Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek
Hazard: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
May 20, 2015Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek
Hazard: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
May 20, 2015Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2
Hazard: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
April 15, 2015Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the
Hazard: The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
April 15, 2015Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with t
Hazard: The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
April 15, 2015Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with t
Hazard: The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
November 26, 2014Medical DevicesFDA
Biomerieux recalls Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for dete
Hazard: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
November 26, 2014Medical DevicesFDA
Biomerieux recalls Etest¿ Ceftaroline (CPT32) US B100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for det
Hazard: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
November 26, 2014Medical DevicesFDA
Biomerieux recalls Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for dete
Hazard: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
November 26, 2014Medical DevicesFDA
Biomerieux recalls Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for dete
Hazard: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
November 26, 2014Medical DevicesFDA
Biomerieux recalls Etest¿ Ceftaroline (CPT32) WW B30. Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for dete
Hazard: The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
March 19, 2014Medical DevicesFDA
Biomerieux Inc recalls bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux,
Hazard: The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.
November 6, 2013Medical DevicesFDA
bioMerieux, Inc. recalls chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of S
Hazard: Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected.
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 RP5800XPE TO
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 6.01 ZH
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 6.01 EL
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 6.01 DA
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 6.01 PT
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 6.01 NO
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 6.01 JA
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 6.01 IT
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 6.01 FR
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 6.01 ES
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 6.01 EN
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 6.01 DE
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