Device 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: 09211101190
Z-1413-2021
Product summary
- Event
- Event 87622
- Status
- Ongoing
- Classification
- Class II
- Quantity
- US: 143,823 kits Ex-US: 57,219 kits
- Official record key
device-enforcement:Z-1413-2021
Official wording
Reason: 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
Code information: All lot numbers
Distribution pattern: Nationwide WorldWide
Derived failure modes
-
Unknown
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