Recall Z-1998-2011 ยท MKW Cyclosporine
Roche Diagnostics Operations, Inc.
Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determination of Cyclosporine in whole blood, using automated clinical analyzers as an aid in management of therapy in kidney, liver, and heart transplants
| Date | Apr 15, 2011 (initiated Aug 13, 2010) |
| Status | Terminated |
| Reason | The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date. |
| Root cause | Other |
| Action | Roche Diagnostics Corporation sent an Urgent Medical Device Removal letter dated 8/13/2011, by UPS ( signature required ) to the consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to discontinue use of affected product upon receipt of replacement product. Consignees were instructed to dispose of the product at their facilities. Therefore, no product returns are anticipated. Questions concerning this recall please call (317) 521-3911. |
| Quantity | 22 kits |
| Distribution | Nationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.