Recall Z-2478-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Operations, Inc.
cobas c513 Analyzer
| Date | Jul 18, 2019 |
| Status | Terminated |
| Reason | Quality issue with high pressure solenoid valves |
| Root cause | Device Design |
| Action | 1. For the cobas 8000 ISE, cobas c 701, and cobas c 702 modules and the cobas c 513 analyzer, stop using these units immediately. Your FES will be in contact with you to replace these affected high pressure solenoid valves immediately. 2. In the event that the high pressure solenoid valves cannot be replaced immediately, for the cobas e 601 module, follow the wash station checks outlined in this Urgent Medical Device Correction (UMDC). Perform these checks once per shift. If these checks show favorable outcomes and quality control results are within range, patient results may be reported. If |
| Quantity | 2 units |
| Distribution | State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay Roche Diagnostics Operations (Rdo), Dec 19, 2016 |