BEUDAMED
    FDA Enforcement Class II Terminated

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    Recall: Z-0937-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0937-2014
    Event ID
    67237
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ITC-Nexus Dx
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    December 19, 2013
    Classification Date
    February 6, 2014
    Termination Date
    October 30, 2014
    Address
    23 Nevsky St, Edison, NJ, 08820-2425, United States

    Description

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    Reason

    ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

    Code Info

    E3JCC013-P1 - exp 2014-05 E3JCC014-P2 - exp - 2014-05 F3JCC015-P3 - exp -2014-06 F3JCC016 - exp - 2014-06 H3JCC017 - exp - 2014-08

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.

    Quantity

    25,965 curvettes (7,425 cuvettes US; 18,540 cuvettes OUS)