BEUDAMED
    FDA Enforcement Class II Terminated

    Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.

    Recall: Z-1301-2018 · Reported April 11, 2018

    Enforcement

    Recall Number
    Z-1301-2018
    Event ID
    79499
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Binding Site Group, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 11, 2018
    Initiation Date
    March 9, 2018
    Classification Date
    April 3, 2018
    Termination Date
    June 22, 2020
    Address
    8 Calthorpe Road, N/A, Birmingham, N/A, N/A, United Kingdom

    Description

    Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.

    Reason

    The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.

    Code Info

    Lot 407460, UDI 05051700017688

    Distribution

    US Distribution was made to CA. There was no foreign/military/government distribution.

    Quantity

    20 kits distributed to the U.S.