Events

Recall of ADVIA Centaur XPT Systems. 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 Healthcare Pty Ltd.

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-2016-RN-00573-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00573-1
  • 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 diagnostics has identified an issue with the advia centaur xpt default setting for the daily maintenance task (or daily cleaning procedure) frequency. instruments may have the daily maintenance task frequency set to “as needed” instead of “daily”. not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results.
  • Action
    Siemens is advising users to not release results generated by the system if quality control results are not within acceptable ranges, and is providing instructions for users to check the daily maintenance tasks. If the frequency is set to "As Needed", users should contact Siemens in order for the frequency to be changed. All systems will be checked during the next scheduled maintenance. Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the Laboratory Director.

Device

ADVIA Centaur XPT Systems. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ADVIA Centaur XPT Systems. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10711433ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA