BEUDAMED
    FDA Enforcement Class II Terminated

    Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings

    Recall: Z-0553-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0553-2018
    Event ID
    78934
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Binding Site Group, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    January 4, 2018
    Classification Date
    February 8, 2018
    Termination Date
    June 9, 2020
    Address
    8 Calthorpe Road, N/A, Birmingham, N/A, N/A, United Kingdom

    Description

    Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings

    Reason

    The low and high controls for the product are returning results above the assigned values.

    Code Info

    Lot #416595, Exp. 31/03/2018; UDI #05051700018319

    Distribution

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

    Quantity

    49 kits to the U.S. office (32 kits further distributed)