BEUDAMED
    FDA Enforcement Class II Ongoing

    xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test

    Recall: Z-0161-2020 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0161-2020
    Event ID
    83472
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Molecular Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2019
    Initiation Date
    July 16, 2019
    Classification Date
    October 18, 2019
    Address
    439 University Ave Suite 900, Toronto, N/A, Canada

    Description

    xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test

    Reason

    The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.

    Code Info

    Catalogue Number:I019C0111 Device UDI: 00840487100462 Lot Numbers: IK019C-0129 IK019C-0130 IK019C-0131 IK019C-0132

    Distribution

    US distribution to CA, CT, MA, and PA OUS: None

    Quantity

    56 Kits