Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, C...
FDA Recall #Z-1019-2026 — Class II — December 5, 2025
Product Description
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Reason for Recall
The affected lots show a decline in performance over time, which may lead to false-negative results.
Recalling Firm
Meridian Bioscience Inc — Cincinnati, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
211 units
Distribution
US Nationwide distribution and the OUS country of Italy.
Code Information
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated