FDA-Device2013-07-03Class II
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).
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
537 meters total
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1582-2013Don't want to check this manually?
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