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CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test ...

FDA Recall #Z-0787-2019 — Class I — December 20, 2018

Recall #Z-0787-2019 Date: December 20, 2018 Classification: Class I Status: Terminated

Product Description

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.

Reason for Recall

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.

Recalling Firm

TERRIFIC CARE LLC — Passaic, NJ

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

793 boxes

Distribution

Nationwide Distribution

Code Information

All Lot Numbers sold by Terrific Care LLC dba Medex Supply

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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