bioMérieux Recalls BacT/ALERT FA Culture Bottles Due to Shipping Exposure
bioMérieux is recalling 2,741 BacT/ALERT FA culture bottles because non-normal shipping conditions may have degraded the media, potentially affecting microbial detection performance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a potential performance defect (media degradation) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
bioMérieux, Inc. is recalling 2,741 units of BacT/ALERT FA culture bottles. These bottles are used with the BacT/ALERT Microbial Detection System to detect aerobic and facultative anaerobic microorganisms, including bacteria and yeast.
The recall is due to the possibility that the bottles were exposed to non-normal shipping conditions. This exposure may have led to media degradation, which could impact the growth performance of the culture bottles. The affected lots are 1042923 (expiring January 25, 2016) and 1042979 (expiring January 28, 2016), with reference number 259791.
The products were distributed in 31 countries, including the United States, France, Germany, and Italy. Healthcare facilities and laboratories should stop using the affected bottles and contact bioMérieux for instructions on return or disposal.
The recalled product
- Product
- BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 2,741
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Reference number: 259791
- Lot number: 1042923
- Expiry: 25JAN2016 and Lot number 1042979
- Expiry: 28JAN2016.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by bioMerieux, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · bioMerieux, Inc.
See all →- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
- HighMedical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
FDA (Devices) · 2023-03-08
Same hazard · performance defect
See all →- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModeratePhilips C5-2 Ultrasound Transducers Refurbished Beyond Useful Life
FDA (Devices) · 2025-07-09
- ModerateThermo SCIENTIFIC Sensititre Mueller-Hinton Broth diagnostic device recalled
FDA (Devices) · 2025-06-18
- ModerateID NOW COVID-19 2.0 Point-of-Care Test Device Recall
FDA (Devices) · 2025-04-23