Events

Recall of ADVIA Centaur & ADVIA Centaur XP Immunoassay System (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-00910-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00910-1
  • 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 is conducting an urgent recall for product correction for the advia centaur and advia centaur xp immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the advia centaur and advia centaur xp immunoassay systems. pushing the sample racks may cause misreads of sample ids (sid) if the sample rack loading instructions are not followed exactly as described in the advia centaur or advia centaur xp operator’s guide.If a sample rack is manually pushed with a slight forward nudge to the entry position without placing it on the rack positioning guide, the barcoded tube sid can be assigned to different positions in the rack. this may lead to misreported results.
  • Action
    Siemens Healthcare Diagnostics is advising the customers that when loading a sample rack, the user must ensure that the sample rack notch rests on the raised area of the sample entry queue and the system automatically moves the rack to the loading position. The raised guide ensures the sample rack is positioned correctly and will accurately scan each barcode as it enters the inprocess queue. Users are further advised not to push the sample racks into the system. During the next service visit, Siemens Healthcare Diagnostics service engineers will affix a label stating "Do not push sample rack" onto the system to reinforce the proper loading technique of the sample rack. This action has been closed-out on 5/08/2016.

Device

ADVIA Centaur & ADVIA Centaur XP Immunoassay System (An in vitro diagnostic medical device (IVD))

Manufacturer

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