BEUDAMED
    FDA Enforcement Class II Terminated

    Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.

    Recall: Z-1588-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1588-2018
    Event ID
    79683
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 9, 2018
    Initiation Date
    February 26, 2018
    Classification Date
    May 1, 2018
    Termination Date
    May 12, 2020
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.

    Reason

    When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers

    Code Info

    UDI 00630414002026

    Distribution

    FL and France Spain Sweden United Kingdom Germany

    Quantity

    N/A