CoaguCheck Test Strip Recall

CoaguCheck Test Strip Recall
Nov 10, 2018 6:26am

Thanks to Ali Sadeghi-Khomami PhD, Precision BioLogic, and Joan Polancic, MS MLS, Denver Health, for the heads-up on this announcemment:

Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, is recalling the CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. Roche re-calibrated the CoaguChek XS PT Test Strips in January 2018 to correspond to a newly released INR International Standard. Since this re-calibration, Roche Diagnostics has received reports of patients experiencing abnormally high or inaccurate INR test results when testing with the affected CoaguChek XS PT Test Strips listed in this FDA link.

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Thanks to Ali Sadeghi-Khomami PhD, Precision BioLogic, and Joan Polancic, MS MLS, Denver Health, for the heads-up on this announcemment:

Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, is recalling the CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. Roche re-calibrated the CoaguChek XS PT Test Strips in January 2018 to correspond to a newly released INR International Standard. Since this re-calibration, Roche Diagnostics has received reports of patients experiencing abnormally high or inaccurate INR test results when testing with the affected CoaguChek XS PT Test Strips listed in this FDA link.

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