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# Class 1 Recall for Roche CoaguCheck Test Strips
- URL: https://www.fdaweb.com/class-1-recall-for-roche-coagucheck-test-strips/
- Published: 2018-11-02T12:00:00.000Z
- Updated: 2026-09-15T00:42:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142736

FDA has classified as Class 1 a Roche Diagnostics recall of its CoaguChek XS PT Test Strips due to inaccurate International Normalized Ratio (INR) test results, when compared to laboratory results. Roche re-calibrated the strips in January to correspond to a newly released INR International Standard. Since the re-calibration, Roche Diagnostics has received reports of patients experiencing abnormally high or inaccurate test results when testing with the affected test strips. “Use of affected products may increase the risk of serious adverse health consequences, including death,” an FDA [recall notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm624822.htm?ref=fdaweb.com) says.