Recall Z-2543-2015 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Roche Molecular Systems, Inc.
cobas Liat Analyzer, for in vitro diagnostic use.
| Date | Sep 2, 2015 (initiated Jul 24, 2015) |
| Status | Terminated |
| Reason | Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers. |
| Root cause | Nonconforming Material/Component |
| Action | Roche sent an Urgent Medical Device Recall letter dated July 24, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Actions Required Identify the affected systems in your inventory by referencing the serial numbers in the table on page 1. You will be contacted to return affected systems for immediate replacement. Complete the attached fax form and fax it to 1-317-521-4815. File this UMDR for future reference. Please contact the Roche Support Network Customer Support Center cobas Liat hotline at 1-800-800-5973, if y |
| Quantity | 5 pieces |
| Distribution | US Distribution to the states of :TX and NC. |
| 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 |