BEUDAMED
    FDA Enforcement Class II Terminated

    Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

    Recall: Z-1108-2017 · Reported February 8, 2017

    Enforcement

    Recall Number
    Z-1108-2017
    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

    Spare Disk Remover Module; Product Number: 61001820 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

    N/A

    Distribution

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

    Quantity

    24 instruments and 3 spare disk remover modules