BEUDAMED
    FDA Enforcement Class II Ongoing

    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

    Recall: Z-1877-2025 · Reported June 4, 2025

    Enforcement

    Recall Number
    Z-1877-2025
    Event ID
    96835
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 4, 2025
    Initiation Date
    April 30, 2025
    Classification Date
    May 29, 2025
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

    Reason

    Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

    Code Info

    Lot# 1475424/ UDI: None

    Distribution

    International distribution in the country of Singapore.

    Quantity

    30 kits