Information for Patients
Our plan to address the CoaguChek XS PT Test Strip calibration issue
Roche Diagnostics is dedicated to offering quality products that deliver the performance you expect for your INR self-testing. Here is what patient self-testers should know about the recent recall of CoaguChek XS PT Test strips. To see Roche Diagnostics' latest media release addressing this recall, click here.
Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek test strips to provide INR test results that correspond to the latest industry standards. Since this calibration, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected CoaguChek test strips. As a result, Roche Diagnostics issued an Urgent Medical Device Correction (UMDC) in September 2018 instructing users to confirm any CoaguChek test results above an INR of 4.5 with another testing method. You may have received a copy of this UMDC in the mail from your test strip supplier.
Roche Diagnostics is now recalling affected CoaguChek XS PT test strips and shipping new lots of CoaguChek XS PT test strips which are not affected by the recall and which do not require testing with another method. We intend to replace all CoaguChek XS PT Test strips affected by the recall with the new unaffected test strips.
Stop using and discard any CoaguChek XS PT Test Strips listed in the table. To see the latest media release indicating lot numbers, click here. Roche started shipping newly calibrated test strips to healthcare providers and patient self-testing service providers. These test strips have been calibrated to the previous INR standard. For questions regarding when you will receive your new test strips, please contact your test strip provider. If you have any questions regarding your testing schedule, please contact your healthcare provider.
If you have questions about this information or have a product complaint, please call Roche Point of Care Technical Support at 1-800-428-4674 24 hours a day, 365 days a year.
Download these resourcesPatient Urgent Medical Device Recall Amendment
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