Roche Molecular Systems, Inc. Recall 87622
Description: cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Roche Molecular Systems, Inc. Recall 87622 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1414-2021 |
| Event ID | 87622 |
| Event Description | cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190 |
| Product Type | Devices |
| Distribution | Nationwide WorldWide |
| Quantity | US: 5,430 units ; OUS 1528 units |
| Recall 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 |
| Device Classification | 20210421 |
| Device Code Info | All serial ID numbers |
| Center Classification Date | 20210412 |
| Recall Initiation Date | 20210325 |
| Recalling Firm | Roche Molecular Systems, Inc. |
| Initial Notification | Letter |
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