Z-1998-2011

Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and...

Name: Z-1998-2011 Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and...
Creator: Roche Diagnostics Operations, Inc.
Published: 2010-08-13
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2010-08-13 / Terminated

FDA source

Roche Diagnostics Operations, Inc. began a recall of Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation... on 2010-08-13. The reason FDA records is "The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1998-2011
Status: Terminated
Initiated: 2010-08-13
Posted: 2011-04-15
Terminated: 2011-05-04
Recalling firm: Roche Diagnostics GmbH
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
Product code: MKW Cyclosporine
Reason for recall: The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date.
FDA root cause: Other
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.
Quantity in commerce: 22 kits
Distribution: Nationwide Distribution -- including, IN, NJ, NY, TX, CA, PA, OH, and FL.
Product codes and lots: Lot number: 70002500

Product code MKW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)