BEUDAMED
    FDA Recall 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 · Initiated February 14, 2016

    Recall

    Recall Number
    Z-2918-2018
    Event Number
    80689
    Firm
    Euro Diagnostica AB
    FEI Number
    3007610287
    Product Code
    NHX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 14, 2016
    Posted
    August 23, 2018
    Terminated
    November 5, 2019
    Address
    Box 50117, Lundavagen 151, Malmo 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.

    Action

    None

    Distribution

    Minnesota and Texas Foreign: Iran

    Quantity

    25 kits (US only)