BEUDAMED
    FDA Enforcement Class II Ongoing

    FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

    Recall: Z-1392-2023 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1392-2023
    Event ID
    91892
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 26, 2023
    Initiation Date
    March 8, 2023
    Classification Date
    April 14, 2023
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

    Reason

    Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

    Code Info

    Pouch Lot# 2N3R22 / Kit Lot# 2160422; UDI-DI: (00)815381020109

    Distribution

    US Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC, NY, OK, WI.

    Quantity

    900 pouches (30 kits)