FDA recall Z-1534-2020

bioMerieux, Inc. · Class II · device

Product

VITEK 2 card AST-N371 - Product Usage: The 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. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

Reason for recall

The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.

Distribution

International distribution in the countries of Germany and the Netherlands.

Key facts

Status
Terminated
Initiation date
2020-02-05
Report date
2020-04-01
Termination date
2022-10-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1534-2020