Events

Recall of Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in vitro diagnostic medical device (IVD))

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00520-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00520-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Siemens has confirmed that there is potential for the vial volume of "in use" vista calibrators, controls or sample diluent to incorrectly revert to full volume when removed and reloaded.If vista vials revert to full volume, insufficient volume may result in the following:- calibrator vial – failed calibration- control vial – low out of range qc- sample diluent vial – auto-diluted results will flag with an above assay range error or a falsely elevated diluted result above the assay range will occur for the following methods: ctni, e2, or tsh.
  • Action
    Siemens is providing temporary work around instructions and is in the process of implementing Vista software version 3.6. Siemens is planning to send additional communication to customers when the software is available.

Device

Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in ...
  • Model / Serial
    Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10488224, 10444802ARTG Number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA