—#179897

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.

FDA product code: N/A
Affected lot / code info: REF: 422024 Lot Number: 0210932204

Why it was recalled

The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: International distribution in the countries of Germany and the Netherlands.

Timeline

Recall initiated: 2020-02-05
Terminated: 2022-10-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179897. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.