BEUDAMED
    FDA Enforcement Class II Terminated

    Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

    Recall: Z-2990-2020 · Reported September 30, 2020

    Enforcement

    Recall Number
    Z-2990-2020
    Event ID
    86248
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2020
    Initiation Date
    August 4, 2020
    Classification Date
    September 21, 2020
    Termination Date
    December 23, 2024
    Address
    10210 Genetic Center Dr, N/A, San Diego, CA, 92121-4362, United States

    Description

    Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000

    Reason

    Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.

    Code Info

    Box/ Tray lots: 271436/ 618539, 271438/ 620899, 272089/ 620899, 272959/ 621837, 272970/ 621256, 272971/ 621837, 274670/ 625351

    Distribution

    U.S. :ID, SC, VT, CA, IL, UT, NJ, MA, TX, AL, CO, FL, ME, NY, VA, WA, WI, OR, DC, GA, NC, HI, CT, OK, TN, O.U.S.: CA, SE, GB, DE, DO, IT, ES, NO, BE, NL, FR, DK, AT

    Quantity

    607