BEUDAMED
    FDA Enforcement Class II Terminated

    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

    Recall: Z-1107-2017 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1107-2017
    Event ID
    76165
    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
    February 8, 2017
    Initiation Date
    January 5, 2017
    Classification Date
    January 27, 2017
    Termination Date
    August 24, 2017
    Address
    Mustionkatu 6, P.O. Box 10, Turku, N/A, N/A, Finland

    Description

    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

    Reason

    The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.

    Code Info

    Serial Numbers: 20210239 20210243 20210244 20210245 20210246 20210247 20210248 20210249 20210250 20210251 20210252 20210253 20210254 20210255 20210256 20210257 20210258 20210259 20210260 20210261 20210262 20210263 20210264 20210265

    Distribution

    MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil

    Quantity

    24 instruments and 3 spare disk remover modules