—#94157

Product

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 product code: MKW — Cyclosporine
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot number: 70002500

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Road, Indianapolis, Indiana 46256-1025

Distribution

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

Timeline

Recall initiated: 2010-08-13
Posted by FDA: 2011-04-15
Terminated: 2011-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94157. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.