Meridian Bioscience Inc recalls Revogene C. difficile
- Recalling company
- Meridian Bioscience Inc
- Product
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Reason
- The affected lots show a decline in performance over time, which may lead to false-negative results.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 5, 2025
- Reported
- Jan 14, 2026
- Distribution
- US Nationwide distribution and the OUS country of Italy.
- Status
- Ongoing
- Quantity
- 211 units
- Lot / codes
- UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
- Company location
- Cincinnati, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1019-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1019-2026 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.