BEUDAMED
    FDA Enforcement Class II Terminated

    Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

    Recall: Z-0027-2018 · Reported October 25, 2017

    Enforcement

    Recall Number
    Z-0027-2018
    Event ID
    78216
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    October 25, 2017
    Initiation Date
    September 15, 2017
    Classification Date
    October 18, 2017
    Termination Date
    July 30, 2020
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362, United States

    Description

    Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

    Reason

    An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.

    Code Info

    Serial Number 20900001124

    Distribution

    Indiana

    Quantity

    1 unit