Class II — Potential Health Hazard

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

Biomerieux Vitek 2 Test kit VITEK 2 is an automated Recalled by bioMerieux, Inc. Due to Potential E. coli Contamination

Date: March 15, 2019
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

Biomerieux Vitek 2 Test kit 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.

Quantity: 10784 cartons

Why Was This Recalled?

Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.

Where Was This Sold?

Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland.

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