Recall Z-2216-2016 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Roche Molecular Systems, Inc.
cobas Liat Analyzer
| Date | May 9, 2016 |
| Status | Terminated |
| Reason | Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results. |
| Root cause | Under Investigation by firm |
| Action | Customers were notified of the recall via phone and email sent on 5/9/2016. They were instructed to take the following actions: Immediately discontinue use of the affected instruments until they have been reworked by a Roche Field Engineering Specialist. A Roche representative will contact you to schedule this service. Complete the attached fax form and fax it to 1-317-521-4815. File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center 1-800-800-5973 if you have questions. |
| Quantity | 2 |
| Distribution | Distributed in NC and WA. |
| 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 |