Recall Z-0828-2022 ยท OOI Real Time Nucleic Acid Amplification System
Roche Molecular Systems, Inc.
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
| Date | Nov 16, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | A Customer Bulletin dated 11/16/21 was sent to customers. Analyzer Return Procedure Our records indicate that you have one of the affected cobas Liat analyzers listed on the previous page. Because of the issue, Roche will send you a new cobas Liat analyzer. Please return your affected analyzer immediately to Roche for investigation by following the steps below: 1. A representative from the Roche Support Network Customer Support Center will contact you to initiate analyzer replacement and confirm shipping information. 2. When you receive the new cobas Liat analyzer from Roche, remove the new a |
| Quantity | 14 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111387 | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER Iquum, Inc., Aug 4, 2011 |