Recall Z-1534-2020— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2020-02-05, terminated 2022-10-28. FDA's recall record names no specific 510(k) clearance for this event. 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: The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-05
- Terminated
- 2022-10-28
- Firm location
- Durham, NC, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.