FDA-Device2020-04-01Class II
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.
bioMerieux, Inc.
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.
Sold states
International distribution in the countries of Germany and the Netherlands.
Affected count
4,130 kits (82,600 cards)
Manufactured in
100 Rodolphe St, N/A, Durham, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1534-2020Don't want to check this manually?
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