BEUDAMED
    FDA Enforcement Class II Ongoing

    K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

    Recall: Z-0271-2023 · Reported November 30, 2022

    Enforcement

    Recall Number
    Z-0271-2023
    Event ID
    91030
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Kamiya Biomedical Company, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 30, 2022
    Initiation Date
    September 28, 2022
    Classification Date
    November 21, 2022
    Address
    12779 Gateway Dr S, N/A, Tukwila, WA, 98168-3308, United States

    Description

    K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

    Reason

    IgA Reagent may start showing cloudiness over time, which can affect assay performance.

    Code Info

    UDI-DI: 00816426020092, Lot/ Expiration Date: H180/ 2023-01-31, K181/ 2023-03-31, N182/ 2023-06-30, D283/ 2023-09-30

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.

    Quantity

    165