BEUDAMED
    FDA Enforcement Class II Terminated

    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports

    Recall: Z-0902-2017 · Reported January 4, 2017

    Enforcement

    Recall Number
    Z-0902-2017
    Event ID
    75817
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Health Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 4, 2017
    Initiation Date
    December 1, 2016
    Classification Date
    December 23, 2016
    Termination Date
    May 1, 2017
    Address
    940 Winter St, N/A, Waltham, MA, 02451-1457, United States

    Description

    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports

    Reason

    Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.

    Code Info

    Software Version 1.0

    Distribution

    Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru

    Quantity

    21