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.
- Company
- Biomerieux, Inc.
- Recall Initiated
- February 5, 2020
- Terminated
- October 28, 2022
- Recall Number
- Z-1534-2020
- Quantity
- 4,130 kits (82,600 cards)
- Firm Location
- Durham, NC
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.
Distribution
International distribution in the countries of Germany and the Netherlands.
Lot / Code Info
REF: 422024 Lot Number: 0210932204
Root Cause
Process control
Action Taken
bioMerieux notified customers on about 02/05/2020 via "Urgent Product Correction Notice." The letter requested customers to check their inventory, destroy any recalled product, ensure the recall notice has been distributed to all appropriate personnel within your organization, and complete and return the attached Acknowledgement form.
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