BEUDAMED
    FDA Recall 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 · Initiated January 3, 2022

    Recall

    Recall Number
    Z-0545-2022
    Event Number
    89370
    Firm
    Immuno-Mycologics, Inc
    FEI Number
    1627497
    Product Code
    GMD
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    January 3, 2022
    Terminated
    May 15, 2024
    Address
    2701 Corporate Centre Dr, Norman, OK, 73069-2901

    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.

    Action

    Customers who received product were contacted via letter Urgent: Medical Device Recall, Cryptococcal Antigen Lateral Flow Assay, dated January 3, 2022, beginning January 3, 2022, to locate and immediately destroy their affected devices. A recall notification and response form was attached to the email that is to be completed by the customers and returned to the firm.

    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