BEUDAMED
    FDA Enforcement Class II Ongoing

    Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

    Recall: Z-0694-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0694-2025
    Event ID
    95731
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hologic, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2025
    Initiation Date
    November 8, 2024
    Classification Date
    December 20, 2024
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362, United States

    Description

    Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

    Reason

    SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.

    Code Info

    UDI-DI: 15420045515352 Kit lot 892307, Expiration: May 15, 2025. Cartridge Lot 890494

    Distribution

    US: AK

    Quantity

    3