BEUDAMED
    FDA Enforcement Class II Ongoing

    In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

    Recall: Z-1253-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1253-2023
    Event ID
    91647
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 22, 2023
    Initiation Date
    February 1, 2023
    Classification Date
    March 15, 2023
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

    Reason

    Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.

    Code Info

    Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322

    Distribution

    U.S. Nationwide distribution in the states of FL and GA.

    Quantity

    2 kits