bioMerieux, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
bioMerieux, Inc.
Lot Codes / Batch Numbers
REF: 422024 Lot Number: 0210932204
Products Sold
REF: 422024 Lot Number: 0210932204
bioMerieux, Inc. is recalling VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, due to The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026