Events

Recall of ADVIA Chemistry XPT System with software versions 1.0.3 and 1.1. 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 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-00569-1
  • 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-00569-1
  • 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 identified multiple software issues that may affect the day-to-day behaviour and/or workflow of the system.1. all levels of qc run when only 1 is selected in start/restart window 2. changing the display name of an assay deselects that method in its associated qc panel, therefore qc for the renamed assay will not run as part of the panel. 3. a workstation services restart screen may appear under multiple scenarios, causing the user interface to be temporarily inaccessible. the user will be prompted to login once the services restart. a.Workstation services may restart if a user defined filter is created in the test results overview screen that includes the 31st day of the month, but is run in a month that does not have 31 days. b.Workstation services may also restart when all items are removed from the watchlist. 4. the chemistry xpt software does not update assay utilisation counters for ise tests when patient samples and qc samples are run in version v1.1.
  • Action
    Siemens is providing users with work around instructions to follow as an interim measure. A software upgrade will be installed as a permanent correction. Users are advised to review the issues with the Medical Director.

Device

ADVIA Chemistry XPT System with software versions 1.0.3 and 1.1. An in vitro diagnostic medical d...
  • Model / Serial
    ADVIA Chemistry XPT System with software versions 1.0.3 and 1.1. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10723034ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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