cobas Liat Analyzer: respiratory virus panel nucleic recall
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Why was cobas Liat Analyzer: respiratory virus panel nucleic 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 serial ID numbers
- Product
- cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- US: 5,430 units ; OUS 1528 units
- Distribution
- Nationwide WorldWide
- Recall date
- April 21, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)