BEUDAMED
    FDA Enforcement Class II Terminated

    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

    Recall: Z-1720-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1720-2016
    Event ID
    73949
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Accriva Diagnostics Inc., dba ITC, dba Accumetrics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    April 22, 2016
    Classification Date
    May 25, 2016
    Termination Date
    December 14, 2016
    Address
    6260 Sequence Dr, N/A, San Diego, CA, 92121-4358, United States

    Description

    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

    Reason

    Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

    Code Info

    Lot #B6JCA012

    Distribution

    U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.

    Quantity

    135 boxes