FDA Enforcement
Class II
Ongoing
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Recall: Z-0568-2026
·
Reported November 26, 2025
Enforcement
- Recall Number
- Z-0568-2026
- Event ID
- 97787
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Meridian Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 26, 2025
- Initiation Date
- October 7, 2025
- Classification Date
- November 19, 2025
- Address
- 3471 River Hills Dr, Cincinnati, OH, 45244-3023, United States
Description
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Reason
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Code Info
UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04
Distribution
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.
Quantity
109 in total