BEUDAMED
    FDA Recall Terminated

    Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.

    Recall: Z-1116-2012 · Initiated January 9, 2012

    Recall

    Recall Number
    Z-1116-2012
    Event Number
    61031
    Firm
    PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6
    FEI Number
    3002808498
    Product Code
    KHO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 9, 2012
    Posted
    February 28, 2012
    Terminated
    March 6, 2013
    Address
    P.O. Box 10, Turku Finland

    Description

    Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.

    Reason

    GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample.

    Action

    Perkin Elmer issued an "Urgent Medical Device Recall" letter dated 1/25/12 to all customers and informed them about the possible issue and requested permission for service personnel to check their instrument. The customers were instructed that the instrument could not be used and the washer module required replacement. Customers were told to expect to be contacted by the firm's local representative for further details.

    Distribution

    Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK.

    Quantity

    10 units