BioMérieux Recalls VITEK 2 GP Cards Due to Quality Control Failures
BioMérieux is recalling VITEK 2 GP ID cards because they are producing atypical negative reactions for a specific quality control strain, causing 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 classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific issue is a quality control failure that affects the reliability of the diagnostic results, rather than a direct physical hazard like injury or death.
Plain-English summary
BioMérieux, Inc. is recalling VITEK 2 GP ID cards (Reference 21342) under FDA recall number Z-3134-2017. The recall involves 11,703 cartons of the product, which is an automated system used for the identification and antimicrobial susceptibility testing of bacteria and yeast.
The recall was initiated due to customer reports of atypical negative O129R reactions for the Enterococcus casseliflavus ATCC 700327 strain. This specific strain is used for quality control (QC) testing and is expected to produce a positive reaction. The atypical negative results are causing the quality control testing for the VITEK 2 GP ID card to fail.
The affected lots are 2420240403 (expiration date July 24, 2018) and 2420303403 (expiration date September 24, 2018). The products were distributed in the United States and numerous international locations, including Canada, Mexico, and various countries in Europe, Asia, Africa, and the Middle East. Users should stop using the affected lots and contact BioMérieux for further instructions.
The recalled product
- Product
- VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes…
- Manufacturer
- Biomerieux Inc
- Affected units
- 11,703
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)
- Lot Number 2420240403
- Exp. 24-JUL-18
- 2420303403
- Exp 24-SEP-2018
Distribution
Distributed in 1 state:
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