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bioMerieux, Inc. recalls VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reage
Recalled April 1, 2020 · FDA recall Z-1534-2020 · bioMerieux
Hazard
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card. · FDA Class II
Units
4,130 kits (82,600 cards)
Sold at
International distribution in the countries of Germany and the Netherlands.
Description
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
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.
Manufacturer(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →