Device product
CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Z-1584-2013
Product summary
- Event
- Event 65246
- Status
- Terminated
- Classification
- Class II
- Quantity
- 86553 meters
- Official record key
device-enforcement:Z-1584-2013
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: 04837975001 and 04625412160
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.