BEUDAMED
    FDA Enforcement Class II Ongoing

    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

    Recall: Z-1518-2025 · Reported April 16, 2025

    Enforcement

    Recall Number
    Z-1518-2025
    Event ID
    96346
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 16, 2025
    Initiation Date
    February 27, 2025
    Classification Date
    April 4, 2025
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

    Reason

    Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

    Code Info

    UDI: 00815381020314/Lot# 0979424

    Distribution

    OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel

    Quantity

    29 kits