Roche Diagnostics Corporation recalls CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS…

Recall date

September 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0360-2019

FDA classification

Class I

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

Nationwide

Why it was recalled

Abnormally high INR test results with the affected CoaguChek test strips

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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;