Reported Apr 24, 2019 · Terminated
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards…
bioMerieux, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: bioMerieux, Inc. · 100 Rodolphe St · Durham, NC · 27712-9402
Is this the product you have?
- 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.
- Lot codes and dates
- Ref413723 (AST-N254), 418674 (AST-N330) and 422024 (AST-N371 Card) with 8.01/9.01
- SW Unique Device Identifier03573026404550 (AST-N254) / 03573026474836 (AST-N330) / 03573026604363 (AST-N371)
- Amount recalled
- 10784 cartons
Why it was recalled
Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.
This product could cause temporary or reversible health problems — stop using it.
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