CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report
Revogene C. difficile, in vitro diagnostic assay intended recalled
Meridian Bioscience is recalling Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene, distributed nationwide in the US. The recall was initiated on 5 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1019-2026
- FDA event ID
- 98038
- Recalling firm
- Meridian Bioscience, Cincinnati, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Dec 2025
- FDA classified
- 5 Jan 2026
- Reported
- 14 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Dec 2025 | Recall initiated by company | |
| 5 Jan 2026 | Classified by FDA | +31 days |
| 14 Jan 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The affected lots show a decline in performance over time, which may lead to false-negative results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Where it was distributed
US Nationwide distribution and the OUS country of Italy.
Questions about this recall
Why was it recalled?
The affected lots show a decline in performance over time, which may lead to false-negative results.
Which lots are affected?
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
Where was it sold?
US Nationwide distribution and the OUS country of Italy.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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