Device product
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Z-1414-2021
Product summary
- Event
- Event 87622
- Status
- Ongoing
- Classification
- Class II
- Quantity
- US: 5,430 units ; OUS 1528 units
- Official record key
device-enforcement:Z-1414-2021
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 serial ID 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