BEUDAMED
    FDA Enforcement Class II Terminated

    Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

    Recall: Z-2918-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2918-2018
    Event ID
    80689
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Euro Diagnostica AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    August 29, 2018
    Initiation Date
    February 14, 2016
    Classification Date
    August 23, 2018
    Termination Date
    November 5, 2019
    Address
    Box 50117, Lundavagen 151, Malmo, N/A, Sweden

    Description

    Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

    Reason

    Decreasing performance overtime.

    Code Info

    Lot # RS 3092, SS 1737

    Distribution

    Minnesota and Texas Foreign: Iran

    Quantity

    25 kits (US only)