BEUDAMED
    FDA Enforcement Class II Terminated

    Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.

    Recall: Z-0595-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0595-2018
    Event ID
    79007
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 21, 2018
    Initiation Date
    January 20, 2018
    Classification Date
    February 12, 2018
    Termination Date
    July 28, 2022
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362, United States

    Description

    Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.

    Reason

    The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.

    Code Info

    Serial Numbers: 2090002307, 2090002308, 2090002309, 2090002310, 2090002311, 2090002312, 2090002339, 2090002340, 2090002341, 2090002342, 2090002343, 2090002344, 2090002345, 2090002346, 2090002347, 2090002348, 2090002349, 2090002350, 2090002351, 2090002352, 2090002353, 2090002359, 2090002360, 2090002361, 2090002362, 2090002363, 2090002366, 2090002367, 2090002368, 2090002369, 2090002370, 2090002371, 2090002372, 2090002373, 2090002374, 2090002381, 2090002382, 2090002383, 2090002384, 2090002385, 2090002387, 2090002388, 2090002389, 2090002390, 2090002391, 2090002393, 2090002404, 2090002405, 2090002406, 2090002407, 2090002409, 2090002411, 2090002413, 2090002414, 2090002415, 2090002420, 2090002421, 2090002422, 2090002428, 2090002429, 2090002430, 2090002432, 2090002433, 2090002434, 2090002435, 2090002436, 2090002437, 2090002438, 2090002446, 2090002447, 2090002448, 2090002449, 2090002450, 2090002451, 2090002452, 2090002458, 2090002462, 2090002465, 2090002466, 2090002467, 2090002468, 2090002469, 2090002470, 2090002471, 2090002472, 2090002473, 2090002476, 2090002481, 2090002483, 2090002484, 2090002485, 2090002338, 2090002394, 2090002417, 2090002431, 2090002463, 2090002464, 2090002492, 2090002491, 2090002490, 2090002489, 2090002488

    Distribution

    Worldwide distribution

    Quantity

    103 units