Events

Recall of ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (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
    Recall
  • Event ID
    RC-2014-RN-00925-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00925-1
  • 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 issue that causes patient demographics data (patient name, age, sex) from the previous order received from the laboratory information system (lis) to be merged with the next order. this issue can occur when the lis data buffer on the advia centaur system becomes full and a particular character (h) is found in the last five locations in the lis data buffer. in this case, the incorrect patient demographic information will be transmitted to the lis and will be displayed on the advia centaur user interface and instrument generated printed reports.
  • Action
    If the ADVIA Centaur and / or ADVIA Centaur XP Immunoassay System is interfaced to a LIS system that transmits patient demographics with each order, the customers are advised to check the event log for the message: “500 03 01 Unknown format message” / rejected results on the LIS. If the message is present, customers are advised to review patient demographic information for all work orders after the time of this event to identify any specific ranges defined for age or sex apply to the order and ensure necessary action is taken for this result.

Device

ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (An in vitro diagnostic medical device (IVD))
  • Model / Serial
    ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (An in vitro diagnostic medical device (IVD))ADVIA Centaur Immunoassay SystemSiemens Material Number: Multiple ADVIA Centaur XP Immunoassay SystemSiemens Material Number: MultipleARTG Number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA