BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2990-2020 · Initiated August 4, 2020

    Recall

    Recall Number
    Z-2990-2020
    Event Number
    86248
    Firm
    Hologic, Inc
    FEI Number
    2024800
    Product Code
    NSU
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 4, 2020
    Terminated
    December 23, 2024
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362

    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.

    Action

    On 08/04/20, Medical Device Recall Notifications were mailed to Laboratory Managers, Site Administrators, and Operators. Customers were asked to do the following: 1. Discontinue use. 2. Immediately check inventory and segregate affected devices. 3. Complete the customer response form. Document the remaining inventory. Destroy the segregated inventory. Return the customer response form even if there is no affected inventory present. 4. There is no other specific actions to the assays. 5. Recalling firm will ship replacement product based on the customer response form information.

    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