bioMérieux Recalls VITEK2 GP-ID Cards Due to Quality Control Failures
bioMérieux is recalling VITEK2 GP-ID cards because atypical negative reactions caused quality control testing failures.
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: The recall is a voluntary precautionary measure addressing quality control failures and atypical reactions, with no reported injuries or illnesses.
Plain-English summary
bioMérieux Inc is recalling 5,672 cartons of VITEK2 GP-ID, REF 21342 IVD cards. The recall includes specific lots and all other GP ID card lots manufactured with the same raw materials. The products were distributed worldwide.
Customers reported, and an internal investigation confirmed, atypical negative O129R reactions for the Enterococcus casseliflavus ATCC 700327 strain. These reactions caused failures in the Quality Control (QC) testing for the VITEK2 GP ID card, where a positive reaction is expected according to the Instructions For Use.
This recall is a precautionary measure to ensure the reliability of the diagnostic cards. Users should stop using the affected lots and contact bioMérieux for further instructions.
The recalled product
- Product
- VITEK2 GP-ID, REF 21342 IVD
- Manufacturer
- Biomerieux Inc
- Affected units
- 5,672
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 (2)
- UDI 03573026131920
- Lot Number 2420348103
Distribution
Distribution scope not specified by the agency.
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 · quality control failure
See all →- High5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- HighEXENT Analyser marked plates as passed without performing quality control
FDA (Devices) · 2026-06-17
- HighPreeclampsia growth factor assay recalled over out-of-range quality control values
FDA (Devices) · 2026-04-15
- ModerateHeparin control material recalled after quality control results fell below acceptance range
FDA (Devices) · 2025-08-20
- SevereHardyCHROM CRE Culture Medium Recalled for Quality Control Failure
FDA (Devices) · 2025-07-09