Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Recall
- Recall Number
- Z-1019-2026
- Event Number
- 98038
- Firm
- Meridian Bioscience Inc
- FEI Number
- 1524213
- Product Code
- OZN
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- December 5, 2025
- Posted
- January 5, 2026
- Address
- 3471 River Hills Dr, Cincinnati, OH, 45244-3023
Description
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
The affected lots show a decline in performance over time, which may lead to false-negative results.
An "URGENT MEDICAL DEVICE CORRECTION" dated 12/1/25 was sent to customers. Required Actions: " Identify and segregate any remaining inventory of impacted product lots and suspend further use. " Destroy remaining inventory of impacted product lot in accordance with state, local, and/or federal regulations. o Contact Technical Service for replacement product. " Review previously obtained results from Revogene C. difficile listed Lots numbers. Any negative results obtained should be re-evaluated in conjunction with presented clinical findings to determine if retesting is required. " Complete and return the CONFIRMATION OF NOTIFICATION Form. Complete this form even if there is no remaining inventory. Actions to Be Taken By Meridian Bioscience, Inc.: Meridian Bioscience, Inc. will replace any unused inventory and provide support for any necessary retesting, including replacement test materials as needed. Contact Information: For any question regarding this notification please call Meridian Bioscience Technical Service at 1-800-343-3858, or email at [email protected].
US Nationwide distribution and the OUS country of Italy.
211 units