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Meridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Recalled January 14, 2026 · FDA recall Z-1019-2026 · Meridian Bioscience
Hazard
The affected lots show a decline in performance over time, which may lead to false-negative results. · FDA Class II
Units
211 units
Sold at
US Nationwide distribution and the OUS country of Italy.
Description
The affected lots show a decline in performance over time, which may lead to false-negative results.
Product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Manufacturer(s)
Meridian Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →