BEUDAMED
    FDA Enforcement Class II Terminated

    CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.

    Recall: Z-1957-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1957-2015
    Event ID
    71362
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2015
    Initiation Date
    May 19, 2015
    Classification Date
    July 2, 2015
    Termination Date
    April 27, 2018
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.

    Reason

    Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system.

    Code Info

    Product: Siemens CentraLink Data Management System, v14.0.5 Material Number (SMN)10811741, 10811742, 10811743, 10814298, 10814877, 10814880,10814881, Product: CentraLink Data Management System, v14.0.8 Material Number (SMN)10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of : Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland and United Kingdom.

    Quantity

    1941