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
This recall has been terminated (originally issued April 15, 2011).
- Recall Initiated
- August 13, 2010
- Posted
- April 15, 2011
- Terminated
- May 4, 2011
- Recall Number
- Z-1998-2011
- Quantity
- 22 kits
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date.
Distribution
Nationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL.
Lot / Code Info
Lot number: 70002500
Root Cause
Other
Action Taken
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.