Recall of ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) reagent kit. 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 have been reports concerning quality control results outside of the expected ranges. siemens has determined that this issue is due to a decrease in the onboard stability of the ehv assay reagents. this issue will be identified by the quality control material.
  • Action
    Siemens is providing work around instructions for users to follow.


  • Model / Serial
    ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) reagent kit. An in vitro diagnostic medical device (IVD)HIV 1/O/2 (EHIV) Readypack Lot Number Ending In: 093, 095, 097, 101, 103, 105, 107, 109Multiple Kit Lots
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source