BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0271-2023 · Initiated September 28, 2022

    Recall

    Recall Number
    Z-0271-2023
    Event Number
    91030
    Firm
    Kamiya Biomedical Company, LLC
    FEI Number
    2084025
    Product Code
    CFF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 28, 2022
    Posted
    November 21, 2022
    Address
    12779 Gateway Dr S, Tukwila, WA, 98168-3308

    Description

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

    Reason

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

    Action

    On 9/28/22, recall notices were sent to customers informing them to stop using affected kit lots and to return complete and partially used kits to the recalling firm. Further, if opaque turbidity is observed, or the controls of the affected assay are not within range, do not report the test results. Distributors are asked to contact their customers and to inform them of the recall. Alternately, distributors can send the recalling firm their customer list so the recalling firm can notify the customers directly. Complete and return the customer acknowledgement. The following firm contacts were provided: (206) 575-8068 and [email protected]

    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