Urgent Medical Device Correction Of CoaguChek PT Test Strips Succeeded

Armen Hareyan's picture

PT Test Strips

Urgent Medical Device Correction issued for CoaguChek PT test strips, used in anticoagulation monitoring, has been addressed and duplicate testing is no longer required for CoaguChek PT Test Strips, lot numbers 560A and higher.


The potential for erroneous prothrombin time (PT) test results that prompted the UMDC was a result of insufficient active ingredient (thromboplastin) on selected test strips. Fully tested and validated changes have been implemented within the manufacturing process to address this concern. Every test strip is inspected to ensure that it contains the correct amount of thromboplastin before being packaged and shipped.

All healthcare professionals performing duplicate testing to confirm results can return to a single test using CoaguChek PT Test Strips (only from lot numbers 560A and higher) to monitor patients on warfarin (anticoagulation) therapy. All patients previously performing patient self-testing may now resume monitoring with CoaguChek PT Test Strips (only from lot numbers 560A and higher).

"Patient safety is Roche Diagnostics' first priority. We are now using an innovative detection system, combined with other measures, to improve our test strip manufacturing process," said Randy Pritchard, Director of Product Marketing, Near Patient Testing, Roche Diagnostics. "We are confident that the potential for erroneous results from inadequate levels of thromboplastin has been addressed, and we are pleased to continue providing healthcare professionals with CoaguChek PT Test Strips and other products that meet the highest standards of quality and patient safety."

Physicians have been using CoaguChek instruments for PT/INR testing at the point of care (POC) since 1994. Today, in the U.S., four out of five POC PT/INR tests are performed using a CoaguChek system (1). The new CoaguChek XS system represents the third generation of point-of-care anticoagulation monitoring devices from Roche Diagnostics.