Revogene C. difficile recall
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Why was Revogene C. difficile recalled?
The affected lots show a decline in performance over time, which may lead to false-negative results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
- Product
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Recalling firm
- Meridian Bioscience Inc
- Quantity
- 211 units
- Distribution
- US Nationwide distribution and the OUS country of Italy.
- Recall date
- January 14, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)