BEUDAMED
    FDA Enforcement Class II Terminated

    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

    Recall: Z-1761-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1761-2017
    Event ID
    76648
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Life and Analytical Sciences, Wallac, OY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    March 7, 2017
    Classification Date
    April 7, 2017
    Termination Date
    May 10, 2021
    Address
    Mustionkatu 6, P.O. Box 10, Turku, N/A, N/A, Finland

    Description

    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

    Reason

    Potential for errors in patient results generated by the Specimen Gate Laboratory Software.

    Code Info

    Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2

    Distribution

    Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil

    Quantity

    29