BEUDAMED
    FDA Enforcement Class II Terminated

    OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

    Recall: Z-1327-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1327-2020
    Event ID
    84729
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Binding Site Group, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 26, 2020
    Initiation Date
    July 29, 2019
    Classification Date
    February 19, 2020
    Termination Date
    January 13, 2022
    Address
    8 Calthorpe Road, Birmingham, N/A, United Kingdom

    Description

    OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

    Reason

    There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.

    Code Info

    Lot # 422251

    Distribution

    CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,

    Quantity

    3294 kits