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U.S. Department of Health and Human Services

Class 3 Device Recall COBAS INTEGRA Cyclosporine Assay

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 Class 3 Device Recall COBAS INTEGRA Cyclosporine Assaysee related information
Date Initiated by FirmAugust 13, 2010
Date PostedApril 15, 2011
Recall Status1 Terminated 3 on May 04, 2011
Recall NumberZ-1998-2011
Recall Event ID 56636
Product Classification Cyclosporine - Product Code MKW
ProductCyclosporine 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
Code Information Lot number: 70002500
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Road
Indianapolis IN 46256-1025
For Additional Information ContactBetsy Cox
317-521-3911 Ext. 249
Manufacturer Reason
for Recall		The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date.
FDA Determined
Cause 2		Other
ActionRoche 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 in Commerce22 kits
DistributionNationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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