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bioMerieux, Inc. recalls Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards des
Recalled April 24, 2019 · FDA recall Z-1137-2019 · bioMerieux
Hazard
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. · FDA Class II
Units
10784 cartons
Sold at
Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.
Description
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.
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(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →