Reported Feb 1, 2023 · Ongoing
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog…
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 SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection
- of RNA from SARSCoV-2 Catalog Number410700
- Lot codes and dates
- UDI
N/A Lot Numbers 410700P019410700P020410700P021410700P022410700P023410700P024410700P027
- UDI
- Amount recalled
- 92 kits
Where it was sold
Why it was recalled
Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
This product could cause temporary or reversible health problems — stop using it.
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