Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Reported: January 14, 2026 Initiated: December 5, 2025 #Z-1019-2026
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.
Details
- Recalling Firm
- Meridian Bioscience Inc
- Units Affected
- 211 units
- Distribution
- US Nationwide distribution and the OUS country of Italy.
- Location
- Cincinnati, OH
Frequently Asked Questions
What product was recalled? ▼
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300. Recalled by Meridian Bioscience Inc. Units affected: 211 units.
Why was this product recalled? ▼
The affected lots show a decline in performance over time, which may lead to false-negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 14, 2026. Severity: Moderate. Recall number: Z-1019-2026.
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