BEUDAMED
    FDA Enforcement Class II Ongoing

    MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above

    Recall: Z-1308-2023 · Reported April 5, 2023

    Enforcement

    Recall Number
    Z-1308-2023
    Event ID
    91772
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Quidel Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2023
    Initiation Date
    February 1, 2023
    Classification Date
    March 30, 2023
    Address
    2005 E State St Ste 100, N/A, Athens, OH, 45701-2125, United States

    Description

    MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above

    Reason

    Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

    Code Info

    UDI: 30014613335580; Lot Number: 213783

    Distribution

    not yet available

    Quantity

    771 units