BEUDAMED
    FDA Enforcement Class II Terminated

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    Recall: Z-0164-2016 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0164-2016
    Event ID
    72311
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sentinel CH SpA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2015
    Initiation Date
    September 22, 2015
    Classification Date
    October 26, 2015
    Termination Date
    March 30, 2016
    Address
    Via Robert Koch 2, N/A, Milano, N/A, N/A, Italy

    Description

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    Reason

    Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

    Code Info

    Lot 50083Y600, expiration date 31 Jul 2016.

    Distribution

    Nationwide Distribution.

    Quantity

    765 kits