Update on CoaguChek XS PT Test Strips

Starting on October 31st, 2018, Roche began shipping new CoaguChek XS PT Test strips which are not affected by the Urgent Medical Device Recall. All distributors of CoaguChek have been shipped the new test strips and have stopped selling the recalled test strips. Roche is committed to replacing all CoaguChek XS PT Test strips affected by the recall with new strips, and we have made significant progress to achieving this.

Here are some of the things Roche has done to resolve the CoaguChek XS PT Test strip issue:

  • Increased production capacity by adding an additional manufacturing shift. We worked around the clock to manufacture the necessary amount of test strips to completely replace affected product in the market.
  • We shipped approximately 3 months worth of the new CoaguChek XS PT Test strips into the market in the month of November. Our goal was to get the new strips to our customers as quickly as possible in order to minimize disruption of patient testing.
  • Roche significantly increased the number of customer support representatives handling CoaguChek calls to reduce call wait times and address inquiries from patients and healthcare professionals.

Read below for more information on what happened and what actions to take if you have any CoaguChek XS PT Test strips which are affected by the recall.

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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