Meridian Bioscience Inc recalls Meridian Bioscience
- Recalling company
- Meridian Bioscience Inc
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 7, 2025
- Reported
- Nov 26, 2025
- 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.
- Status
- Ongoing
- Quantity
- 109 in total
- Lot / codes
- UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04
- Company location
- Cincinnati, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0568-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0568-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.