Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VITEK 2 card AST-N371 - Product Usage: The VITEK 2 Recalled by bioMerieux, Inc. Due to The top seal of some of the pouches...

Date: February 5, 2020
Company: bioMerieux, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact bioMerieux, Inc. directly.

Affected Products

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.

Quantity: 4,130 kits (82,600 cards)

Why Was This 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.

Where Was This Sold?

International distribution in the countries of Germany and the Netherlands.

About bioMerieux, Inc.

bioMerieux, Inc. has 53 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report