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 AST-ST01 Streptococcus Susceptibility Card Recalled by Biomerieux Inc Due to The product package did not contain the correct...

Date: February 6, 2013
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 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.

Quantity: 4/20-card cartons

Why Was This Recalled?

The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.

Where Was This Sold?

This product was distributed to 1 state: HI

Affected (1 state)Not affected

About Biomerieux Inc

Biomerieux Inc has 368 total recalls tracked by RecallDetector.

Related Recalls

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