BEUDAMED
    FDA Enforcement Class III 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 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1101-2017
    Event ID
    75949
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Health Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    December 21, 2016
    Classification Date
    January 26, 2017
    Termination Date
    October 3, 2018
    Address
    940 Winter St, N/A, Waltham, MA, 02451-1457, United States

    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

    Code Info

    Batch Code: 649552 OUS: 649552, 649552

    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)