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Meridian Bioscience Inc: Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

Medical DevicesSource: FDA (device) · Date: 2026-01-14

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Meridian Bioscience Inc
Product
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Reason / hazard
The affected lots show a decline in performance over time, which may lead to false-negative results.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution and the OUS country of Italy.
Recall initiated
2025-12-05
Code info
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Product quantity
211 units
Voluntary mandated
Voluntary: Firm initiated
City
Cincinnati
State
OH
Country
United States
Event id
98038
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