TERRIFIC CARE LLC recalls CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the Co…

Recall date

December 20, 2018

Source

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

Recall number

Z-0787-2019

FDA classification

Class I

Brand / firm

TERRIFIC CARE LLC

Sold / distributed

Nationwide Distribution

Why it was recalled

Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba MedEx Supply via website/telephone/facsimile.

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 PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.