Roche Diagnostics CoaguChek Test Strips

Roche Diagnostics CoaguChek Test Strips

Date of Recall: October 31, 2018

Recalling Firm(s): Roche Diagnostics

Products:  CoaguChek XS Professional, CoaguChek XS Pro, CoaguChek XS Plus, CoaguChek XS PST and CoaguChek Vantus.

Scope of Recall: Please click on the link below to view a list of all recalled catalog numbers and associated lot numbers.

Description: Roche Diagnostics initiated a recall for CoaguChek XS PT test strips which it distributed directly to U.S. consumers. Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek XS PT Test Strips to provide INR test results that correspond to the most recent INR International Standard. Since this calibration, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected. These products have been found to inaccurately report high International Normalized Ratio (“INR”) test results.

Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.

For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm626140.htm

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