BEUDAMED
    FDA Recall Open, Classified

    xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.

    Recall: Z-1767-2019 · Initiated February 22, 2019

    Recall

    Recall Number
    Z-1767-2019
    Event Number
    82745
    Firm
    Luminex Molecular Diagnostics
    FEI Number
    3002777243
    Product Code
    PCH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 22, 2019
    Address
    439 University Ave, Toronto Canada Suite 900

    Description

    xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.

    Reason

    Reports have been received of lower MS2 MFI values when using the panel.

    Action

    The recalling firm issued letters via email dated 2/22/2019.

    Distribution

    Distribution from the firm's Austin, Texas, location was made to AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, and WI. There was military distribution but no government distribution.

    Quantity

    965 kits