BEUDAMED
    FDA Enforcement Class II Terminated

    ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.

    Recall: Z-2347-2019 · Reported August 28, 2019

    Enforcement

    Recall Number
    Z-2347-2019
    Event ID
    83487
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aniara Diagnostica LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 28, 2019
    Initiation Date
    July 19, 2019
    Classification Date
    August 22, 2019
    Termination Date
    June 11, 2021
    Address
    7768 Service Center Dr, N/A, West Chester, OH, 45069-2442, United States

    Description

    ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.

    Reason

    Residual crystallization of the microplate and recurrent negative controls out of range.

    Code Info

    F1701571

    Distribution

    Distribution to US states of NC, NH, NY, and OH, and Sweden.

    Quantity

    46