[pending] Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Cata
Pending LLM rewrite. Source: FDA_DEVICE Z-1019-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The affected lots show a decline in performance over time, which may lead to false-negative results.
The recalled product
- Product
- Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Manufacturer
- Meridian Bioscience Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 00840733102349
- Lot Numbers: 410300U195
- 410300U196
- 410300U197
- 410300U201
Distribution
Distributed nationwide across the United States.
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