BEUDAMED
    FDA Enforcement Class II Terminated

    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

    Recall: Z-2088-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2088-2014
    Event ID
    68659
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ITC-Nexus Dx
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    June 20, 2014
    Classification Date
    July 21, 2014
    Termination Date
    December 11, 2014
    Address
    23 Nevsky St, Edison, NJ, 08820-2425, United States

    Description

    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.

    Reason

    Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.

    Code Info

    Lot Number A4JCA001

    Distribution

    Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.

    Quantity

    US- 315 cuvettes; OUS - 2835 cuvettes