BEUDAMED
    FDA Recall Terminated

    Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

    Recall: Z-1101-2017 · Initiated December 21, 2016

    Recall

    Recall Number
    Z-1101-2017
    Event Number
    75949
    Firm
    PerkinElmer Health Sciences, Inc.
    FEI Number
    3006159931
    Product Code
    KHO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 21, 2016
    Terminated
    October 3, 2018
    Address
    940 Winter St, Waltham, MA, 02451-1457

    Description

    Program Update Package AutoDELFIA 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry

    Reason

    AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

    Action

    PerkinElmer issued letter on 12/21/16 to customers with AutoDELFIA Systems running version 3.0 Manager Software (revisons 1 and 2). The issue cannot be corrected by the customer therefore it is recommended the AutoDELFIA System be operated in the default English language variant until the AutoDELFIA Manager Software can be updated. The AutoDELFIA System with version 3.0 Manager Software performs as intended when the selected language variant is English. Customers are recommended to implement a software update to be deployed by PerkinElmer to resolve the issue. AutoDELFIA Manager Software version 3.0 revision 1 or 2 will be updated through the correction to revision 3 or the latest released revision

    Distribution

    Worldwide Distribution - US Nationwide in the state of MN and countries of China, India, Philippines, France, South Korea, Vietnam, Taiwan, Morocco, Kazachstan, UK, Spain, and Israel,

    Quantity

    1 unit (US) 2 units (OUS)