cobas SARS-CoV-2 & Influenza A/B assay cobas Liat recall
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number…
Why was cobas SARS-CoV-2 & Influenza A/B assay cobas Liat recalled?
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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
- cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number…
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- US: 143,823 kits Ex-US: 57,219 kits
- Distribution
- Nationwide WorldWide
- Recall date
- April 21, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)