Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Recalled by Meridian Bioscience Inc Due to Emergency Use Application (EUA) application withdrawn as false...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Meridian Bioscience Inc directly.
Affected Products
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19
Quantity: 376 kits of the Revogene SARS-CoV-2 assay
Why Was This Recalled?
Emergency Use Application (EUA) application withdrawn as false negative results reported
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Meridian Bioscience Inc
Meridian Bioscience Inc has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report