BEUDAMED
    FDA Recall 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 · Initiated March 9, 2018

    Recall

    Recall Number
    Z-1301-2018
    Event Number
    79499
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    JZG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 9, 2018
    Terminated
    June 22, 2020
    Address
    8 Calthorpe Road, Birmingham 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.

    Action

    The recalling firm notified their U.S. location by letter dated 3/6/2018 via email on 3/9/2018.

    Distribution

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

    Quantity

    20 kits distributed to the U.S.