BEUDAMED
    FDA Enforcement Class II Ongoing

    Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.

    Recall: Z-1369-2021 · Reported April 14, 2021

    Enforcement

    Recall Number
    Z-1369-2021
    Event ID
    87557
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 14, 2021
    Initiation Date
    February 26, 2021
    Classification Date
    April 7, 2021
    Address
    10210 Genetic Center Dr, N/A, San Diego, CA, 92121-4362, United States

    Description

    Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.

    Reason

    There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.

    Code Info

    Part No. (PN) FAB-15004 (Box Lot Number)/Catalog No PRD-0400 (Box/Tray Lot Number) 285762 / 647288, 285765 / 647288, 286025 / 648958, 286026 / 648958, 286028 / 648959, 286852 / 650655, 287410 / 650656, 289297 / 648959, 290057 / 647288, 290068/654833, 290409 / 654833, 291425 / 657545

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium (BE), France (FR), Germany (DE), Great Britain (GB), Italy (IT) Netherlands (NL), Spain (ES), Switzerland (CH),, Canada (CA), Hong Kong (HK), Australia (AU), New Zealand (NZ).

    Quantity

    1355 kits