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Terminated

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.

FDA Recall Z-1534-2020 · Posted None

Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Product CodeN/A
Date Initiated2020-02-05
Date Terminated2022-10-28
Product Quantity4,130 kits (82,600 cards)

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

International distribution in the countries of Germany and the Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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