bioMerieux, Inc. recalls VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an aut
Recalled 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.
Hazard / Issue
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
Issued by
FDA
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