BEUDAMED
    FDA Enforcement Class II Ongoing

    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

    Recall: Z-2440-2023 · Reported August 30, 2023

    Enforcement

    Recall Number
    Z-2440-2023
    Event ID
    92397
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 30, 2023
    Initiation Date
    May 8, 2023
    Classification Date
    August 21, 2023
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

    Reason

    Due to manufacturing issue, panels may result in false negative results.

    Code Info

    Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482

    Distribution

    US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia

    Quantity

    24 Kits (30 pouches/kit)