Meridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Recall date
- December 5, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1019-2026
- FDA classification
- Class II
- Brand / firm
- Meridian Bioscience Inc
- Sold / distributed
- US Nationwide distribution and the OUS country of Italy.
Why it was recalled
The affected lots show a decline in performance over time, which may lead to false-negative results.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
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