BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-0787-2019 · Reported February 13, 2019

    Enforcement

    Recall Number
    Z-0787-2019
    Event ID
    81857
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    TERRIFIC CARE LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    February 13, 2019
    Initiation Date
    December 20, 2018
    Classification Date
    February 1, 2019
    Termination Date
    December 29, 2020
    Address
    61 Willet St, Bldg A-1, Fl 2, Passaic, NJ, 07055-1971, United States

    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

    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.

    Code Info

    All Lot Numbers sold by Terrific Care LLC dba Medex Supply

    Distribution

    Nationwide Distribution

    Quantity

    793 boxes