Events

Recall of Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical chemistry analyser. 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-00649-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00649-1
  • 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 healthcare has confirmed that, under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a qc or calibrator product from a vista vial. if two samples are dispensed into the same aliquot well, the first sample will always be qc or calibrator from a vista vial. patient sample will never be dispensed into an aliquot well that contains another patient sample.
  • Action
    In the event of an instrument reset, end users are requested to check if there are any QC or calibration tests pending. If there are QC or calibrations pending a software restart is necessary before resuming patient processing. If there is no QC or calibration pending reset or troubleshoot the instrument as per the Operators Guide. A software update will be provided as a permanent fix.

Device

Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical che...
  • Model / Serial
    Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical chemistry analyser. An in vitro diagnostic medical device (IVD)Siemens Material Numbers: 10488224 and 10444802ARTG Number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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