BEUDAMED
    FDA Recall Terminated

    Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.

    Recall: Z-2121-2012 · Initiated June 27, 2012

    Recall

    Recall Number
    Z-2121-2012
    Event Number
    62512
    Firm
    Perkinelmer
    FEI Number
    3006159931
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 27, 2012
    Posted
    August 1, 2012
    Terminated
    April 18, 2014
    Address
    940 Winter Street, Waltham, MA, 02451

    Description

    Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.

    Reason

    Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT

    Action

    PerkinElmer sent an Urgent: Medical Device Recall letter dated June 27, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that replacement units of the recalled product will be installed as soon as they are available. Customers were instructed to complete and return the response form attached. For further information contact your local PerkinElmer representative or GS. [email protected]

    Distribution

    Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,

    Quantity

    78 units