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 RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Recalled by Meridian Bioscience Inc Due to Emergency Use Application (EUA) application withdrawn as false...

Date: April 8, 2021
Company: Meridian Bioscience 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 Meridian Bioscience Inc directly.

Affected Products

Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file

Quantity: 124 Revogene RNA Software Upgrade Kits

Why Was This Recalled?

Emergency Use Application (EUA) application withdrawn as false negative results reported

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