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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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