BEUDAMED
    FDA Recall Terminated

    CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

    Recall: Z-2220-2024 · Initiated April 26, 2024

    Recall

    Recall Number
    Z-2220-2024
    Event Number
    94739
    Firm
    Centers For Disease Control and Prevention
    FEI Number
    1050190
    Product Code
    OZE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 26, 2024
    Posted
    June 27, 2024
    Terminated
    February 5, 2025
    Address
    1600 Clifton Rd Ne, Atlanta, GA, 30329-4018

    Description

    CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

    Reason

    The H5b component may fail to amplify, resulting in an inconclusive result.

    Action

    The CDC notified customers via letter on 04/26/2024. Customers were instructed to halt use of the H5b component when testing a specimen with the CDC Influenza A/H5 subtyping kit, lot 220307. Proceed with testing with the InfA, H5a, and RP targets and do not delay resulting. If a specimen is positive for InfA and H5a, that is considered a presumptive H5 positive and should be sent to CDC immediately. Please reach out to [email protected] for further shipping guidance. If a specimen is positive for InfA and negative for H5a and has not been tested with the Influenza A Subtyping kit, proceed to testing the specimen with the Influenza A Subtyping kit. If a specimen is negative for all viral targets but positive for RP, that specimen is considered negative for Influenza A, H5. Please reach out to [email protected] with any inconclusive results.

    Distribution

    US Nationwide distribution.

    Quantity

    191 units