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.
Z-1534-2020
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 84993
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,130 kits (82,600 cards)
- Official record key
device-enforcement:Z-1534-2020
Official wording
Reason: The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
Code information: REF: 422024 Lot Number: 0210932204
Distribution pattern: International distribution in the countries of Germany and the Netherlands.
Derived failure modes
-
Unknown
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.