BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0907-2025 · Initiated December 13, 2024

    Recall

    Recall Number
    Z-0907-2025
    Event Number
    95948
    Firm
    Hologic, Inc.
    FEI Number
    2024800
    Product Code
    NJR
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 13, 2024
    Posted
    January 14, 2025
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362

    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.

    Action

    An Urgent Medical Device Recall Notification letter issued 12/13/2024 via Fed Ex. The letter instructs customers to discontinue use of the Panther Fusion GBS Assay kit lot 715927 containing cartridge lot 624907 and segregate and count the number of affected Panther Fusion GBS Assay kits from lot 715927 containing cartridge lot 624907. Customers are instructed to destroy the product and fill out the online Customer Response Form (CRF) indicating that the on-hand inventory of recalled Panther Fusion GBS Assay Kit has been destroyed. If you have any questions or concerns regarding this recall notification, please contact Hologic Technical Support at +1 888 484 4747 or +1 858 410 8511 during the hours of 5 am PT and 5 pm PT, or by e-mail at [email protected].

    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