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Roche Diagnostics Operations, Inc. recalls CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quanti
Recalled July 3, 2013 · FDA recall Z-1584-2013 · 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
86553 meters
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 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.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →