Drug Safety Alerts

CoaguChek XS PT Test Strips Class I Recall

11/01/18

On November 1, 2018, Roche Diagnostics issued a Class I recall of CoaguChek XS PT 48 Test Strips, CoaguChek XS PT 6 Test Strips and CoaguChek XS Test 24 Tests USA. This recall was issued 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 at the end of this document.

Use of affected products may increase the risk of serious adverse health consequences, including death.

A complete list of the affected products is provided here:

Refer to the pictures below for an example of the location of the lot number on the test strip box and test strip vial.

The FDA recommends that health care providers and patient self-testers should stop using and discard any remaining supply of affected strips (lot numbers 27216700 through 33449899). Health care providers and patient self-testers should switch to new batches of test strips that are calibrated to the previous international standard. The FDA is recommending that patients contact their health care provider and patient self-testing service providers immediately to determine alternative test methods and address questions regarding their testing schedule.

The manufacturer has stated that the following lots of CoaguChek XS PT Test Strips, which are now available, have been calibrated to the previously used International Reference Preparation (IRP) rTF/09 standard to address the potential for inaccurately high INR test results:

CVS Caremark Response: The CVS Caremark mail service pharmacies were not impacted by this recall. We are encouraging patients who are using CoaguChek XS PT Test Strips to contact their prescriber.

For more information about this recall, please call Roche Diagnostics Point-of-Care Technical Service, 24 hours a day, seven days a week toll-free at 1-800-428-4674 or visit www.coaguchek-usa.com/. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.