BEUDAMED
    FDA Recall Terminated

    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.

    Recall: Z-2864-2017 · Initiated June 27, 2017

    Recall

    Recall Number
    Z-2864-2017
    Event Number
    77697
    Firm
    Hologic, Inc
    FEI Number
    2024800
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 27, 2017
    Terminated
    June 30, 2023
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362

    Description

    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.

    Reason

    A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.

    Action

    Hologic initiated the recall on Tuesday, June 27, 2017. The method of notification with either: A letter will be provided at a face-to-face meeting with a Hologic representative. Customers will be contacted by phone and electronically sent the letters. The letters will be delivered in one of the following ways: A Hologic representative will hand-deliver the recall letter to the laboratory management. Or Customers will be contacted by phone and electronically sent the letters. The letter states the problem and that a software fix is available. Those with who have the problem will have priority repair.

    Distribution

    Worldwide distribution. US Nationwide and countries: BE, CA, CH, ES, FR, GB, IE, IT, JP, LU, NL, SE, SK, and TR.

    Quantity

    164 units