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Roche Diagnostics Operations, Inc. recalls CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative p
Recalled July 3, 2013 · FDA recall Z-1583-2013 · 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
3343 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 Plus System The CoaguChek XS Plus system 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 →