BEUDAMED
    FDA Enforcement Class II Ongoing

    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

    Recall: Z-0907-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0907-2025
    Event ID
    95948
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hologic, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    December 13, 2024
    Classification Date
    January 14, 2025
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362, United States

    Description

    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

    Reason

    Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.

    Code Info

    UDI-DI: 15420045510890, Kit Lot 715927, containing Cartridge Lot 624907, Exp. Date 2025-08-15.

    Distribution

    AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.

    Quantity

    380