Recall Z-0044-2020 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Roche Diagnostics Operations, Inc.
AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
| Date | Aug 13, 2019 |
| Status | Terminated |
| Reason | AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results |
| Root cause | Process change control |
| Action | Roche Diagnostics issued Urgent Medical Notification letter to Distributor (TP-00744) and end users( TP-00741) on 8/13/19. Letter identifies problem, health risk and Actions required per the UMDC: " Check to see if you have any of the affected lot number(s) of AssayTips/AssayCup Trays on your cobas e 801 module or in your laboratory stock. (See pictures for lot number locations on packaging.). " Stop using the affected lot number(s) of AssayTips/AssayCup Trays immediately. " Discard the affected lot number(s) of AssayTips/AssayCup Trays according to your local waste management guidelines. To |
| Quantity | 935 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer Roche Diagnostics, Jan 23, 2017 |