Roche coagulation test strips now OK

May 28, 2007

Roche Diagnostics has announced a resolution to a problem with its CoaguChek PT test strips, which were the subject of an Urgent Medical Device Correction issued last October after the strips showed random falsely high INR test results.

Roche Diagnostics has announced a resolution to a problem with its CoaguChek PT test strips, which were the subject of an Urgent Medical Device Correction issued last October after the strips showed random falsely high INR test results. At the time, the company recommended healthcare professionals duplicate the test to confirm the results and reduce the risk of inaccurate findings. Due to concerns that patient self-testers would not know how to conduct or interpret duplicate results, it was recommended that patients discontinue use of the strips. Now, practitioners can return to using a single test strip to monitor patients on anticoagulation therapy and self-testers may once again resume monitoring their INR levels with the CoaguChek PT strips. According to Roche, the problem stemmed from inadequate levels of thromboplastin on the test strip.

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