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Recall Observatory FDA recall evidence

Device product

CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.

Z-1583-2013

May 16, 2013

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 65246
Status
Terminated
Classification
Class II
Quantity
3343 meters
Official record key
device-enforcement:Z-1583-2013

Official wording

Reason: Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.

Code information: Model/Catalog/Part Number: 05021537001

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.