FDA-Device2013-07-03Class II
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.
Roche Diagnostics Operations, Inc.
Hazard
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.
Sold states
Nationwide Distribution
Affected count
86553 meters
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1584-2013Don't want to check this manually?
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