BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 19, 2019

    Enforcement

    Recall Number
    Z-1767-2019
    Event ID
    82745
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Molecular Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 19, 2019
    Initiation Date
    February 22, 2019
    Classification Date
    June 10, 2019
    Address
    439 University Ave Suite 900, N/A, Toronto, N/A, N/A, Canada

    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.

    Code Info

    Lot numbers IK032C-00061, exp. 11/30/2018; IK032C-00063, exp. 11/30/2018; IK032C-00064, exp. 12/31/2018; IK032C-00066, exp. 12/31/2018; IK032C-00067, exp. 11/30/2018; IK032C-00068, exp. 4/30/2019; IK032C-00069, exp. 7/31/2019; and IK032C-00071, exp. 12/31/2018; UDI 00840487100493.

    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