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:
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK¿ 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton.
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton.
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton.
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Neisseria-Haemophilus identification card (NH), IVD, REF 21346, 20 cards per carton.
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Yeast identification card (YST), IVD, REF 21343, 20 cards per carton. .
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Gram-Positive identification card (GP), IVD, REF 21342, 20 cards per carton.
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
June 21, 2017Medical DevicesFDA
Biomerieux Inc recalls VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
Hazard: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
May 18, 2016Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gra
Hazard: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
May 18, 2016Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gra
Hazard: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
May 18, 2016Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gra
Hazard: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
May 18, 2016Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gra
Hazard: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
May 18, 2016Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gra
Hazard: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
May 18, 2016Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gra
Hazard: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
May 18, 2016Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 G
Hazard: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
May 18, 2016Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gr
Hazard: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
May 18, 2016Medical DevicesFDA
Biomerieux Inc recalls Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gra
Hazard: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
May 11, 2016Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Car
Hazard: Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
February 10, 2016Medical DevicesFDA
bioMerieux, Inc. recalls BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial
Hazard: Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
February 10, 2016Medical DevicesFDA
bioMerieux, Inc. recalls BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial
Hazard: Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
January 6, 2016Medical DevicesFDA
Biomerieux Inc recalls Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalac
Hazard: FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
December 30, 2015Medical DevicesFDA
Biomerieux recalls Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicr
Hazard: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
December 30, 2015Medical DevicesFDA
Biomerieux recalls Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicr
Hazard: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
December 30, 2015Medical DevicesFDA
Biomerieux recalls Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrob
Hazard: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
December 30, 2015Medical DevicesFDA
Biomerieux recalls Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for dete
Hazard: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
December 23, 2015Medical DevicesFDA
bioMerieux, Inc. recalls MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 tec
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 CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 tec
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 V4.1 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.