Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

CoaguChek XS PT Test Recalled by TERRIFIC CARE LLC Due to Potential for abnormally high INR test results with...

Date: December 20, 2018
Company: TERRIFIC CARE LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact TERRIFIC CARE LLC directly.

Affected Products

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.

Quantity: 793 boxes

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About TERRIFIC CARE LLC

TERRIFIC CARE LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report