Recall of ADVIA Centaur and ADVIA Centaur XP HBsAg II Assay. 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 Ltd Diagnostics Division.

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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • 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
    There is an increased number of falsely elevated patient samples for hbsagii resulting in the number of initial positives reactive rates exceeding the initial reactive specificity as listed in the instructions for use (ifu). the increased false reactive rate may cause a delay in reporting results because additional testing is required.
  • Action
    Siemens is providing work around instructions for users to implement.


  • Model / Serial
    ADVIA Centaur and ADVIA Centaur XP HBsAg II Assay. An in vitro diagnostic medical device (IVD)ADVIA Centaur and ADVIA Centaur XP HBsAg II (HBsII) AssayReference Number: 10492138Kit Lot numbers: 93076013, 94615013, 95344013, 95801013, 96628013, 98117014, 98508014, 12536014An in vitro diagnostic medical device (IVD)
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source