BEUDAMED
    FDA Enforcement Class II Terminated

    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

    Recall: Z-1541-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1541-2018
    Event ID
    79421
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Life and Analytical Sciences, Wallac, OY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 9, 2018
    Initiation Date
    November 17, 2017
    Classification Date
    April 27, 2018
    Termination Date
    August 12, 2021
    Address
    Mustionkatu 6, P.O. Box 10, Turku, N/A, N/A, Finland

    Description

    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

    Reason

    Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.

    Code Info

    All software versions from 1.0 to 1.8 (current software version)

    Distribution

    Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.

    Quantity

    8