Meridian Bioscience Inc: Device Recall

Recall #Z-1019-2026 · 12/05/2025

Class II: Risk

Recall Details

Recall Number: Z-1019-2026
Classification: Class II
Product Type: Device
Recalling Firm: Meridian Bioscience Inc
Status: Ongoing
Date Initiated: 12/05/2025
Location: Cincinnati, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 211 units

Reason for Recall

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

Product Description

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

Distribution Pattern

US Nationwide distribution and the OUS country of Italy.

Other Recalls by Meridian Bioscience Inc

Class II: Risk 10/07/2025

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Class II: Risk 10/07/2025

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

View all recalls by Meridian Bioscience Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.