Class II

Medical Device Recall: Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

Meridian Bioscience Inc · December 5, 2025

Reason for Recall

The affected lots show a decline in performance over time, which may lead to false-negative results.

Distribution

US Nationwide distribution and the OUS country of Italy.

States Affected

NATIONWIDE

Quantity Affected

211 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1019-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.