Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by:
FDA device recall Z-1998-2011 · posted 2011-04-15 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKW
- Quantity affected
- 22 kits
- Distribution
- Nationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL.
- Date initiated
- 2010-08-13
- Date posted
- 2011-04-15
- Date terminated
- 2011-05-04
- Location
- Indianapolis, IN
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