FDA recall, , Moderate risk
Meridian Bioscience Revogene C. Difficile Assay
The Revogene C. difficile assay may show a decline in performance over time, leading to false-negative results.
Summary by Recall Canary from the FDA notice
What happened
Meridian Bioscience Inc, based in Cincinnati, Ohio, recalled the Revogene C. difficile in vitro diagnostic assay intended for use with the Revogene instrument. The affected lots show a decline in performance over time, which may lead to false-negative results. The recall began on December 5, 2025, and involves 211 units with distribution across the US Nationwide and the OUS country of Italy.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- UDI-DI
- 00840733102349
- Lot code
- 410300U195
- 410300U196
- 410300U197
- 410300U201
Recall details
- Company began the recall
- Sold in
US Nationwide distribution and the OUS country of Italy.
- Company
- Meridian Bioscience IncCincinnati, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98038
- Recall number
- Z-1019-2026
- Quantity recalled
- 211 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
