bioMerieux Recalls VITEK 2 AST-N351 Test Kits Due to False Positives
bioMerieux, Inc. is recalling VITEK 2 AST-N351 Test Kits distributed in the UK and Ireland because they may produce false positive results for ESBL phenotypes.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (incorrect clinical diagnosis) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
bioMerieux, Inc. is recalling 30,292 cartons of VITEK 2 AST-N351 Test Kits. The recall affects all lots of Reference 421257. These products were distributed in the United Kingdom and Ireland.
The recall was initiated because the test kits may produce false positive results for the Extended-Spectrum Beta-Lactamase (ESBL) phenotype. This issue could lead to incorrect clinical interpretations of bacterial resistance.
Healthcare facilities and distributors in the UK and Ireland should stop using the affected test kits and contact bioMerieux, Inc. for further instructions or a return.
The recalled product
- Product
- VITEK 2 AST-N351 Test Kit
- Manufacturer
- bioMerieux, Inc.
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 (1)
- Ref: 421257 ALL LOTS
Distribution
Distribution scope not specified by the agency.
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