BEUDAMED
    FDA Enforcement Class II Terminated

    FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only

    Recall: Z-1451-2020 · Reported March 18, 2020

    Enforcement

    Recall Number
    Z-1451-2020
    Event ID
    84825
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2020
    Initiation Date
    August 8, 2019
    Classification Date
    March 6, 2020
    Termination Date
    April 12, 2022
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248, United States

    Description

    FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only

    Reason

    Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.

    Code Info

    Kit Lot: 0537319 / Pouch Lot: 681619 Pouch Lot Date of Expiration 2020-05-30

    Distribution

    US: KY, IL, NJ, MS

    Quantity

    23 kits (690 pouches)