Events

Recall of Dimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab System

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-2014-RN-01192-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01192-1
  • 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 received customer complaints of discrepant flagged and un-flagged patient and qc results on dimension vista intelligent lab systems. siemens healthcare diagnostics has confirmed that 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.
  • Action
    Siemens is providing additional instructions to assist laboratories in determining when the replace the reagent probe.

Device

Dimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab System
  • Model / Serial
    Dimension Vista 500 Intelligent Lab System & Dimension Vista 1500 Intelligent Lab SystemDimension Vista 500 Intelligent Lab SystemCatalogue number: 10488224Dimension Vista 1500 Intelligent Lab SystemCatalogue number: 10444802ARTG number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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