CoaguChek Test Strips

CoaguChek Test Strips

Date of Recall: December 19, 2018

Recalling Firm(s): Terrific Care, LLC. / Medex Supply Dist, Inc.

Product: CoaguChek XS Test Strips

Scope of Recall: All catalog/reference numbers that do not end in 160. Affected Lot Numbers: 27216700 through 33449899

Description: Terrific Care and Medex Supply initiated a nationwide recall of Roche CoaguChek test strips which it distributed directly to U.S. consumers between December 27, 2017 and December 15, 2018 via courier service. 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.

This recall is related to the recent Roche Diagnostics Recall. 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.

For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm628976.htm.

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