Recall Z-0297-2016 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Operations, Inc.
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
| Date | Nov 18, 2015 (initiated Sep 22, 2015) |
| Status | Terminated |
| Reason | Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing. |
| Root cause | Device Design |
| Action | Roche Diagnostics Operations, Inc. sent an Urgent Medical Device Correction letter to affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were asked to retain the Urgent Medical Device Correction letter until a Roche Field Service Representative has installed the BLM modification kit. Consignees were also asked to complete the attached form and fax to 1-877-906-8982, ext 2015. Consignees with questions were instructed to call 1-800-428-2336. For questions regarding this recall call 317-521-3911. |
| Quantity | 1 |
| Distribution | Distributed to TX only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.