BEUDAMED
    FDA Enforcement Class II Terminated

    FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

    Recall: Z-1944-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1944-2021
    Event ID
    87936
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 30, 2021
    Initiation Date
    April 16, 2021
    Classification Date
    June 24, 2021
    Termination Date
    April 2, 2024
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

    Reason

    Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

    Code Info

    Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621

    Distribution

    U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None

    Quantity

    9 kits (U.S. only)