FDA recall Z-1137-2019

bioMerieux, Inc. · Class II · device

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.

Reason for recall

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.

Distribution

Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.

Key facts

Status
Terminated
Initiation date
2019-03-15
Report date
2019-04-24
Termination date
2021-08-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2019