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Recall Observatory FDA recall evidence

Device product

CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).

Z-1582-2013

May 16, 2013

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 65246
Status
Terminated
Classification
Class II
Quantity
537 meters total
Official record key
device-enforcement:Z-1582-2013

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: 05530199160

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.