BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0027-2018 · Initiated September 15, 2017

    Recall

    Recall Number
    Z-0027-2018
    Event Number
    78216
    Firm
    Hologic, Inc
    FEI Number
    2024800
    Product Code
    NSU
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 15, 2017
    Terminated
    July 30, 2020
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362

    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.

    Action

    The customer was notifed of the potential incorrect results via a phone call on September 15, 2017. A customer letter was sent on September 18, 2017. The notification letter requests the customer to re-test any negative Aptima Combo 2 assay results tested between July 13, 2017 Aug 30, 2017.

    Distribution

    Indiana

    Quantity

    1 unit