Events

Recall of ADVIA Centaur XPT System

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-00720-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00720-1
  • 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 issues with all the advia centaur xpt system software versions that may affect the results generated by the system as described below:1. there is potential for discrepant qc and patient results. stop running the system until it is serviced if the conditions occur. the probability of this failure occurring is extremely unlikely.2. if the daily cleaning procedure (dcp) fails to complete there is potential for discrepant qc and patient results. the probability of this failure occurring is unlikely but possible if bulk fluids are not filled prior to starting the dcp.3. there is potential for delayed results noticeable to the user as either absence of results or an error posted for the sample. no erroneous results will be reported.Siemens advises the overall risk to health is low.
  • Action
    Siemens is asking users to follow the detailed instructions in the customer letter.

Device

ADVIA Centaur XPT System
  • Model / Serial
    ADVIA Centaur XPT SystemSiemens Material Number: 10711433All the ADVIA Centaur XPT system software 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) and V1.1 (Bundle 1.1.243 SMN 11221979)ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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