BEUDAMED
    FDA Enforcement Class III Terminated

    FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

    Recall: Z-1448-2020 · Reported March 11, 2020

    Enforcement

    Recall Number
    Z-1448-2020
    Event ID
    84887
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biofire Defense
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2020
    Initiation Date
    August 20, 2019
    Classification Date
    March 5, 2020
    Termination Date
    October 30, 2020
    Address
    79 W 4500 S, Ste 14, Salt Lake City, UT, 84107-2649, United States

    Description

    FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

    Reason

    The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.

    Code Info

    Lot No./Expiration Date 457117D/2018-10-17 416118D/2019-03-15 439218D/2019-06-12 439318D/2019-07-18 454218D/2019-08-21 454318D/2019-08-22 455518D/2019-08-23 458118D/2019-09-18 458218D/2019-09-19 458018D/2019-09-20 464018D/2019-10-02 425719D/2020-05-30 462819D/2020-06-10

    Distribution

    US: UT, MD, GA, CO, OH, TX, OUS: None

    Quantity

    92 kits