FDA-Device2026-01-14Class II
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Meridian Bioscience Inc
Hazard
The affected lots show a decline in performance over time, which may lead to false-negative results.
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-1019-2026Don't want to check this manually?
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