BEUDAMED
    FDA Enforcement Class II Terminated

    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.

    Recall: Z-1907-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1907-2019
    Event ID
    82979
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Phadia Ab
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2019
    Initiation Date
    May 10, 2019
    Classification Date
    July 1, 2019
    Termination Date
    June 2, 2020
    Address
    Rapsgatan Plant, Rapsgatan 7, Uppsala, N/A, N/A, Sweden

    Description

    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.

    Reason

    Potential for reporting low assay results

    Code Info

    UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085

    Distribution

    US Nationwide n the states of NJ, NY, MI, WV, TX including PR

    Quantity

    30 kits