BEUDAMED
    FDA Enforcement Class II Terminated

    CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919

    Recall: Z-0545-2022 · Reported February 9, 2022

    Enforcement

    Recall Number
    Z-0545-2022
    Event ID
    89370
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Immuno-Mycologics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 9, 2022
    Initiation Date
    January 3, 2022
    Classification Date
    January 31, 2022
    Termination Date
    May 15, 2024
    Address
    2701 Corporate Centre Dr, N/A, Norman, OK, 73069-2901, United States

    Description

    CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919

    Reason

    The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.

    Code Info

    F1021035 and F1021036

    Distribution

    US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.

    Quantity

    411 kits