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Roche Diagnostics Operations, Inc. recalls CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantita
Recalled July 3, 2013 · FDA recall Z-1582-2013 · Roche Diagnostics Operations
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. · FDA Class II
Units
537 meters total
Sold at
Nationwide Distribution
Description
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.
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).
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →