FDA-Device2013-07-03Class II
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
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
204,205 meters total
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1581-2013Don't want to check this manually?
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