Information for Healthcare Professionals

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 at the point of care. To help you provide the best care to your patients, here is what you should know about the recent recall of CoaguChek XS PT Test strips. To see Roche Diagnostics' latest media release addressing this recall, click here.

What Happened?

Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek XS PT Test Strips to the most recent International Normalized Ratio (INR) Standard. Since calibrating to this new standard, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected test strips. As a result, Roche Diagnostics issued an Urgent Medical Device Correction (UMDC) in September 2018 instructing patients and healthcare practitioners to confirm any CoaguChek test results above an INR of 4.5 with another testing method. This UMDC was distributed to CoaguChek distributors, customers, healthcare professionals and patients via mail.

Roche Diagnostics is now recalling affected CoaguChek XS PT test strips and shipping new lots of CoaguChek XS PT Test Strips that are not affected by the recall and do not require testing with another method. We intend to replace all CoagChek XS PT Test Strips in the market that are affected by the recall with new unaffected test strips as quickly as possible.

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. Also, please advise your self-testing patients to do the same. Roche Diagnostics has started shipping unaffected test strips to healthcare providers, patient self-testing service providers and distribution partners.

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.

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Video Resources

Roche Video PT INR Testing: Calibration, Correlation, Concordance
- Marcia Zucker is an established professional with recognized expertise in the medical diagnostics industry and a specialist in point of care testing applications. She is a member of the AACC Academy and has served as Chair of the Critical and Point-of-Care Testing (CPOCT) Division of the American Association for Clinical Chemistry (AACC)

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