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Roche Diagnostics Corporation recalls CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek X
Recalled November 14, 2018 · FDA recall Z-0360-2019 · Roche Diagnostics
Hazard
Abnormally high INR test results with the affected CoaguChek test strips · FDA Class I
Units
1,163,952 boxes
Sold at
Nationwide
Description
Abnormally high INR test results with the affected CoaguChek test strips
Product
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;
Manufacturer(s)
Roche Diagnostics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →