Events

Recall of ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – Hbs

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-00817-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00817-1
  • 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 error on the advia centaur confirmatory card that is included in the advia centaur hbsagii kit lot numbers 55825056, 56167056 and 56244056. the error causes an interpretation of ‘invalid’ and a flag of ‘conf n/a’ when the hbsagii positive control is tested with the hbsagii confirmatory (conf) assay.
  • Action
    Siemens is advising laboratories that the affected ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT HBsAgII kit lots may only be used to generate HBsAgII screening results, however, an alternate lot or alternate method must be used for reporting confirmed results, if confirmatory testing is required. Siemens can assist laboratories in procuring unaffected stock if they rely on the HBsAgII kit for confirmatory testing. This action has been closed-out on 05/12/2016.

Device

ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – Hbs
  • Model / Serial
    ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – HbsAgII AssayCatalogue Number: SMN 10492138Lot Numbers: 55825056, 56167056, 56244056ARTG Number: 239120
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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