BEUDAMED
    FDA Recall Terminated

    ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.

    Recall: Z-2346-2019 · Initiated July 19, 2019

    Recall

    Recall Number
    Z-2346-2019
    Event Number
    83487
    Firm
    Aniara Diagnostica LLC
    FEI Number
    3005017664
    Product Code
    LCO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 19, 2019
    Terminated
    June 11, 2021
    Address
    7768 Service Center Dr, West Chester, OH, 45069-2442

    Description

    ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.

    Reason

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

    Action

    The firm notified customers of the recall via Urgent Medical Device Correction emails dated July 26, 2019. Customers were informed of the recall and asked to destroy the affected kits in stock and indicate the quantity in the Awareness Acknowledgement Form, which was to be signed and returned to the local distributor. If you have any questions regarding this recall, please contact Aniara at (513) 360-6377, or [email protected].

    Distribution

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

    Quantity

    51