FDA-Device2019-04-24Class II
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.
bioMerieux, Inc.
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.
Sold states
Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.
Affected count
10784 cartons
Manufactured in
100 Rodolphe St, N/A, Durham, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief