bioMerieux Recalls Vitek 2 Test Kits Due to False ESBL Results
bioMerieux is recalling Vitek 2 test kits because they may incorrectly identify Escherichia coli as having an ESBL phenotype.
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 that may provide incorrect diagnostic results (false ESBL phenotype), which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
bioMerieux, Inc. is recalling 10,784 cartons of Vitek 2 test kits, specifically the AST-N254, AST-N330, and AST-N371 cards. The VITEK 2 system is an automated device used for the identification and antimicrobial susceptibility testing of bacteria and yeast.
The recall was initiated because the test kits may propose an unexpected Extended Spectrum Beta Lactamase (ESBL) phenotype for some Escherichia coli strains. This error could lead to incorrect identification of bacterial resistance patterns.
The affected products were distributed internationally to the United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland. Users should stop using the affected test kits and contact bioMerieux, Inc. for further instructions.
The recalled product
- Product
- Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 10,784
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: 413723 (AST-N254)
Distribution
Distribution scope not specified by the agency.
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