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 SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection Recalled by Meridian Bioscience Inc Due to Leakage of the original specimen from the plastic...

Date: December 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 SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700

Quantity: 92 kits

Why Was This Recalled?

Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2

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