Revogene SARS-CoV-2 recall
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the…
Why was Revogene SARS-CoV-2 recalled?
Emergency Use Application (EUA) application withdrawn as false negative results reported
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot numbers
- Product
- Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the…
- Recalling firm
- Meridian Bioscience Inc
- Quantity
- 376 kits of the Revogene SARS-CoV-2 assay
- Distribution
- Nationwide
- Recall date
- May 19, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)