Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
FDA device recall Z-1019-2026 · posted 2026-01-05 · Open, Classified
Recall details
- Recalling firm
- Meridian Bioscience Inc
- Reason for recall
- The affected lots show a decline in performance over time, which may lead to false-negative results.
- Action taken
- 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 FieldActionSupport@meridianbioscience.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OZN
- Quantity affected
- 211 units
- Distribution
- US Nationwide distribution and the OUS country of Italy.
- Date initiated
- 2025-12-05
- Date posted
- 2026-01-05
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GenePOC CDiff (K172569) | Genepoc, Inc. | 2017-11-22 |