Z-2003-2009

Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number...

Name: Z-2003-2009 Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number...
Creator: Roche Diagnostics Operations, inc.
Published: 2009-07-22
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2009-07-22 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, inc. began a recall of Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS... on 2009-07-22. The reason FDA records is "The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2003-2009
Status: Terminated
Initiated: 2009-07-22
Posted: 2009-09-03
Terminated: 2011-04-27
Recalling firm: Roche Diagnostics GmbH
Product: Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.
Product code: GJS Test, Time, Prothrombin
Reason for recall: The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
Root cause tag: design
FDA root cause: Device Design
Action: Roche Diagnostics Operations, Inc. notified Consignees by letter dated July 22, 2009 informing them of the problem and instructing them to use revised cleaning procedures. For further questions, contact Roche Diagnostics Operations, Inc. at 1-317-521-3194.
Quantity in commerce: 27,784 in US
Distribution: Worldwide Distribution
Product codes and lots: All serial numbers.

Product code GJS

K062925Class IICoaguchek Xs SystemRoche Diagnostics Corp. / cleared 2007-01-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)