BEUDAMED
    FDA Enforcement Class II Terminated

    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

    Recall: Z-0604-2019 · Reported December 19, 2018

    Enforcement

    Recall Number
    Z-0604-2019
    Event ID
    81421
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Binding Site Group, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2018
    Initiation Date
    November 6, 2018
    Classification Date
    December 13, 2018
    Termination Date
    April 27, 2021
    Address
    8 Calthorpe Road, N/A, Birmingham, N/A, N/A, United Kingdom

    Description

    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.

    Reason

    Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.

    Code Info

    Lot 413849

    Distribution

    U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,

    Quantity

    60