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FDASeptember 13, 2018device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Abnormally high INR test results with the affected CoaguChek test strips

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

UPCs

04625375160046253741600779782616004625315160

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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