Class IIReported 2026-01-14

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

Recalled by Meridian Bioscience Inc

Reason for Recall

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

Recall Number

Z-1019-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-05

Reported

2026-01-14

Distribution

US Nationwide distribution and the OUS country of Italy.

Code Info

UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.