Events

Recall of ADVIA Centaur XPT System with software versions V1.0 to V1.2. 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-2017-RN-00208-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00208-1
  • 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
    Multiple software issues have been identified for software versions v1.0 to v1.2. these issues may affect the operation and workflow of the advia centaur xpt system, and the potential exists for an apparent delay to testing. the issues are detailed in the customer letter and relate to the following: system status unknown, las communication, qc profiles, 'no primary' error, and lis specification.
  • Action
    The software issues will be corrected in future software versions. In the interim, Siemens is providing detailed work around instructions in the customer letter. It is recommended that the letter is reviewed with the laboratory Medical Director.

Device

ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical devi...
  • Model / Serial
    ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD).Siemens Material Number: 10711433Software versions: V1.0.1 (Bundle 1.0.912 SMN 10819704)V1.0.2 (Bundle 1.0.1086 SMN 11219806)V1.0.3 (Bundle 1.0.1108 SMN 11220781, 11219656)V1.1 (Bundle 1.1.243 SMN 11221979, 11222064)V1.2 (Bundle: 1.2.223.0 SMN: 11222258, 11223813)ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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