Revogene C. difficile, in vitro diagnostic assay intended… recallZ-1019-2026 · Meridian Bioscience Inc · initiated Dec 5, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Meridian Bioscience Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The affected lots show a decline in performance over time, which may lead to false-negative results.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-1019-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 5, 2025
- Posted by the FDA
- Jan 5, 2026
- Recalling firm
- Meridian Bioscience Inc
- Quantity
- 211 units
- Product code
- OZN
- FDA submissions
- K172569
- Distribution
- US Nationwide distribution and the OUS country of Italy.
Product description
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Code information (models, lots, serial numbers)
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Revogene C. difficile 410300Meridian Bioscience, Inc. · C. Difficile Toxin Gene Amplification Assay1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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