Recall of ADVIA Centaur XPT. 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-2015-RN-01043-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-29
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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 multiple issues with the advia centaur xpt system software v1.0.1 (bundle 1.0.912 smn 10819704) and v1.0.2 (bundle 1.0.1086 smn 11219806).
  • Action
    Users are provided a detailed workaround in the customer letter whilst a software upgrade is being scheduled.

Device

  • Model / Serial
    ADVIA Centaur XPT. An in vitro diagnostic medical device (IVD)Catalogue Number: 10711433ARTG Number: 175890An in vitro diagnostic medical device (IVD)
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    DHTGA