Recall Z-1090-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Corporation
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
| Date | Jan 24, 2017 (initiated Dec 27, 2016) |
| Status | Terminated |
| Reason | |
| Root cause | Software design |
| Action | On 12/27/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected Consignees via courier fax or email. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The cobas p 612 pre-analytical system (63x) software is being revised to correct the aspiration process. We anticipate this new version (2.0.4) to be available during Quarter 1 2017. For now, discontinue using disposable non-filter tips for Aliquotting on your cobas p 612 pre-ana |
| Quantity | 5 |
| Distribution | TX and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.