Reported Apr 6, 2022 · Ongoing
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded…
Meridian Bioscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Meridian Bioscience Inc · 3471 River Hills Dr · Cincinnati, OH · 45244-3023
Is this the product you have?
- Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories
- Meridian branded RevogeneCatalog
- Number 610210 GenePOC branded RevogeneCatalog Number 130840
- Lot codes and dates
- UDI00840733102318 All units in the field, all serial numbers
- Amount recalled
- 452 units (398 US, 54 OUS)
Where it was sold
Why it was recalled
The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
This product could cause temporary or reversible health problems — stop using it.
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