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Terminated

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

FDA Recall Z-1998-2011 · Posted 2011-04-15

Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeMKW
Date Initiated2010-08-13
Date Terminated2011-05-04
Product Quantity22 kits

Reason for Recall

The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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