FDA recall Z-0360-2019

Roche Diagnostics Corporation · Class I · device

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;

Reason for recall

Abnormally high INR test results with the affected CoaguChek test strips

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2018-09-13
Report date: 2018-11-14
Termination date: 2020-10-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0360-2019