Class II — Potential Health Hazard

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

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic Recalled by Biomerieux Inc Due to Major errors (Resistant result instead of Susceptible result)...

Date: June 24, 2021
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

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Quantity: 1,431

Why Was This Recalled?

Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)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