Class II — Potential Health Hazard

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

Revogene C. difficile Recalled by Meridian Bioscience Inc Due to The affected lots show a decline in performance...

Date: December 5, 2025
Company: Meridian Bioscience Inc
Status: Ongoing
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 Meridian Bioscience Inc directly.

Affected Products

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

Quantity: 211 units

Why Was This Recalled?

The affected lots show a decline in performance over time, which may lead to false-negative results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Meridian Bioscience Inc

Meridian Bioscience Inc has 15 total recalls tracked by RecallDetector.

Related Recalls

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