Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips Recalled by Roche Diagnostics Corporation Due to Abnormally high INR test results with the affected...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Corporation directly.
Affected Products
CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;
Quantity: 1,163,952 boxes
Why Was This Recalled?
Abnormally high INR test results with the affected CoaguChek test strips
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Diagnostics Corporation
Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report