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.
FDA Recall Z-2003-2009 · Posted 2009-09-03
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Recalling FirmRoche Diagnostics Operations, inc.
Recall StatusTerminated
Product CodeGJS
Date Initiated2009-07-22
Date Terminated2011-04-27
Product Quantity27,784 in US
Reason for Recall
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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