Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, is recalling the CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. Roche re-calibrated the CoaguChek XS PT Test Strips in January 2018 to correspond to a newly released INR International Standard. Since this re-calibration, Roche Diagnostics has received reports of patients experiencing abnormally high or inaccurate INR test results when testing with the affected CoaguChek XS PT Test Strips listed in the table below. The manufacturing and distribution dates were between January 12, 2018 – October 29, 2018.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
All patients who have been prescribed the blood thinner warfarin (also known by the brand names Coumadin and Jantoven) to prevent and treat blood clots.
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Patients with the following conditions are at especially high risk for serious events associated with inaccurate INR measurements:
- Mechanical heart valve
- Atrial fibrillation and high-risk CHA2DS2-VASc scores
- Recent thromboembolic events
Patients and health care providers should switch to new batches of test strips that are calibrated to the previous international standard, which Roche Diagnostics will provide to customers within one month.
Patients should also contact their patient self-testing service providers to find out when they will be receiving corrected test strips
Patients who are using CoaguChek meters and CoaguChek XS PT Test Strips affected by the recall should contact their health care provider and patient self-testing service providers immediately to determine alternative test methods and address questions regarding their testing schedule.
Patients should consult with their health care provider before making any changes to their warfarin dose.
Health care providers and patients with questions may contact Roche Diagnostics at 1-800-428-4674 to learn more details about the recall.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
For additional information, visit the FDA website.