BEUDAMED
    FDA Enforcement Class II Terminated

    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

    Recall: Z-2166-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2166-2014
    Event ID
    68670
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Health Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2014
    Initiation Date
    June 27, 2014
    Classification Date
    August 7, 2014
    Termination Date
    April 6, 2015
    Address
    940 Winter St, N/A, Waltham, MA, 02451-1457, United States

    Description

    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

    Reason

    Potential for demographic information and test result to be mismatch.

    Code Info

    Product Code: 5002-0500; Software Versions, 1.4 and 1.6

    Distribution

    Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK

    Quantity

    13 devices