Recall Z-1019-2026— Meridian Bioscience Inc
Class II · Ongoing
Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2025-12-05. It names one FDA 510(k) clearance: K172569. Product: Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300. Reason: The affected lots show a decline in performance over time, which may lead to false-negative results..
- Recalling firm
- Meridian Bioscience Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-12-05
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.