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 Recalled by Meridian Bioscience Inc Due to The photomultiplier tube, may have compromised functionality in...

Date: February 15, 2022
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, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840

Quantity: 452 units (398 US, 54 OUS)

Why Was This Recalled?

The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate 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