BEUDAMED
    FDA Recall Completed

    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.

    Recall: Z-2134-2019 · Initiated February 21, 2018

    Recall

    Recall Number
    Z-2134-2019
    Event Number
    82952
    Firm
    Hycor Biomedical Inc
    FEI Number
    1000125787
    Product Code
    DHR
    Status
    Completed
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 21, 2018
    Address
    7272 Chapman Ave, Garden Grove, CA, 92841-2103

    Description

    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.

    Reason

    Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.

    Action

    On 02/21/19, Urgent Field Safety Notices were mailed to customers advising them to immediately discontinue testing and to either return or destroy remaining affected product. Further, customers were advised to share this information with laboratory staff, retain this notification as part of their laboratory documentation, and to complete and return the Field Safety Notice & Acknowledgement Form. Customers with additional questions were encouraged to call: 714-933-3000

    Distribution

    U.S.: TX. Foreign (OUS): Netherlands, Belgium, Austria, Italy, India

    Quantity

    207