Recall of ADVIA Centaur and ADVIA Centaur XP (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
    Siemens healthcare diagnostics has identified an issue that on some systems a slight cracking of the tubing (the tubing for the wash 1, acid, and base bottle reservoirs) at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. the cracking may result in a minor drip of fluid onto the reservoir and into the drip tray located underneath the reservoirs. the potential for minimal fluid leakage outside the system exists. the drip will cause the reservoir to empty faster than the system expects. once the acid and base fluids are depleted, the system detects it and will flag all subsequent results with a signal error flag, once the lack of acid/base solution is detected. when wash 1 fluid becomes low, the system will detect it and stop processing samples. in this case, a limited number of test results (up to 20 tests) processed prior to a signal error may be affected and not flagged.
  • Action
    Siemens is advising the customers to examine their system to see if there is any fluid in the reservoir drip tray. If fluid is present, the customer is advised to contact their Siemens Customer Care Center or local Siemens technical support representative to schedule a visit. Until a service engineer has inspected their system for this issue, Siemens recommends that the customers replace the bulk bottle for all fluids immediately when the yellow warning appears. This will help mitigate the possibility of improper fluid dispenses. Siemens service engineers will inspect the tubing on the next service visit and replace the tubing if necessary. This action has been closed-out on 11/08/2016.


  • Model / Serial
    ADVIA Centaur and ADVIA Centaur XP (An in vitro diagnostic medical device (IVD))Multiple Catalogue NumbersBulk Fluid Reserve Assembly (Acid & Base)Siemens Material Numbers: 10282187 & 10483525Wash 1 Reservoir ConnectorSiemens Material Numbers: 10364516 & 10483526ARTG Number: 175890
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source