FDA-Device2018-11-14Class I
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;
Roche Diagnostics Corporation
Hazard
Abnormally high INR test results with the affected CoaguChek test strips
Sold states
Nationwide
Affected count
1,163,952 boxes
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0360-2019Don't want to check this manually?
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