BEUDAMED
    FDA Enforcement Class II Terminated

    Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

    Recall: Z-0274-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0274-2022
    Event ID
    88921
    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 1, 2021
    Initiation Date
    October 15, 2021
    Classification Date
    November 19, 2021
    Termination Date
    February 4, 2025
    Address
    8 Calthorpe Road, Birmingham, N/A, United Kingdom

    Description

    Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

    Reason

    Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.

    Code Info

    Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664

    Distribution

    U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada

    Quantity

    2,254 kits