Roche Molecular Systems, Inc. Recall 89643
Description: cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Roche Molecular Systems, Inc. Recall 89643 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0828-2022 |
| Event ID | 89643 |
| Event Description | cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong. |
| Quantity | 14 units |
| Recall Reason | Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results. |
| Device Classification | 20220406 |
| Device Code Info | UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086 |
| Center Classification Date | 20220328 |
| Recall Initiation Date | 20211116 |
| Recalling Firm | Roche Molecular Systems, Inc. |
| Initial Notification | Letter |
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