BEUDAMED
    FDA Enforcement Class II Ongoing

    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

    Recall: Z-2081-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2081-2026
    Event ID
    98719
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2026
    Initiation Date
    April 1, 2026
    Classification Date
    May 6, 2026
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248, United States

    Description

    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

    Reason

    Respiratory/sore throat panel test may result in false negative results and control failures.

    Code Info

    Lot Number: 2215125/UDI: 00815381020390

    Distribution

    US Nationwide distribution in the states of MS, TX MN, VA.

    Quantity

    2400 pouches