FDA-Device2026-01-14Class IIPROCESSING DEFECT
Meridian Bioscience Revogene C. difficile assay recalled for declining performance and false-negative results
What this means
Meridian Bioscience's Revogene C. difficile diagnostic test (a lab assay used with the Revogene instrument) may show declining accuracy over time in certain lots. This could produce false-negative results, meaning the test might not detect C. difficile infection when it is present.
- Stop using affected lots: 410300U195, 410300U196, 410300U197, 410300U201
- Contact Meridian Bioscience for guidance on replacement or alternative testing
- Review recent test results from these lots with your lab director or healthcare provider
The agency's original wording
Hazard
The affected lots show a decline in performance over time, which may lead to false-negative results.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution and the OUS country of Italy.
Affected count
211 units
Manufactured in
3471 River Hills Dr, Cincinnati, OH, United States
Products
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2026Want us to check the next one for you?
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