BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

    Recall: Z-0838-2015 · Reported December 31, 2014

    Enforcement

    Recall Number
    Z-0838-2015
    Event ID
    69687
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 31, 2014
    Initiation Date
    November 5, 2014
    Classification Date
    December 20, 2014
    Termination Date
    October 6, 2017
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.

    Reason

    Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.

    Code Info

    Material Nos.: 10284473, 10488224, 10444801, and 10444802

    Distribution

    Worldwide Distribution -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, and United States.

    Quantity

    1,949