Meridian Bioscience Inc: Device Recall

Recall #Z-0568-2026 · 10/07/2025

Class II: Risk

Recall Details

Recall Number: Z-0568-2026
Classification: Class II
Product Type: Device
Recalling Firm: Meridian Bioscience Inc
Status: Ongoing
Date Initiated: 10/07/2025
Location: Cincinnati, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 109 in total

Reason for Recall

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

Product Description

Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Distribution Pattern

US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.

Other Recalls by Meridian Bioscience Inc

Class II: Risk 12/05/2025

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