Recall Z-2173-2017 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Roche Diagnostics Corporation
Elecsys PreciControl Varia 3
| Date | May 31, 2017 (initiated Apr 10, 2017) |
| Status | Terminated |
| Reason | e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays |
| Root cause | Process control |
| Action | On 4/10/2017, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected consignees via courier. 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. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. |
| Quantity | 1603 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111506 | ELECSYS PRECICONTROL VARIA 3 Roche Diagnostics, Jul 8, 2011 |