Recall of Prostate-specific antigen (PSA) Assay performed on ADVIA Centaur, Centaur XP, Centaur XPT, and Centaur CP Analysers. An in vitro diagnostic medical device (IVD).PSA Assay (100 Tests)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

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 has become aware that serial psa measurements at values <0.2ng/ml are being used to monitor patients for biochemical recurrence of prostate cancer post-radical prostatectomy. the risk to health is limited to scenarios where the threshold for biochemical recurrence is defined independent of the 2013 american urological association (aua) guidelines or 2015 european association of urology (eau) guidelines which define recurrence of prostate cancer as a detectable or rising psa value post-radical prostatectomy that is =0.2 ng/ml (ug/l) with a second confirmatory level of =0.2 ng/ml (ug/l). in scenarios, where clinicians use the psa assay in accordance with clinical guidelines for biochemical recurrence there is negligible risk to health.In a recent study, the limit of quantitation (loq) level for the advia centaur/xp/xpt psa assay was evaluated and determined to be 0.04 ng/ml at the level of 20% within laboratory precision. this applies to all lots of advia centaur psa.
  • Action
    Siemens is providing a letter to emphasize that PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. The use of PSA thresholds < 0.2 ng/mL (ug/L) to identify biochemical recurrence of prostate cancer is not recommended. Where clinicians decide to use a PSA value <0.2 ng/mL (ug/L) as a threshold for identifying patients who may be experiencing biochemical recurrence, the potential exists for unnecessary follow-up &/or treatment for progression of residual disease. Any clinician choosing to use PSA in this manner should be aware of current clinical guidance & the limitations of PSA assays. Siemens is advising users to review the information with the lab's Medical Director. Siemens is not recommending a lab review of previously generated results; however, this is at the discretion of the lab. For more information, please see . This action has been closed-out on 10/05/2017.


  • Model / Serial
    Prostate-specific antigen (PSA) Assay performed on ADVIA Centaur, Centaur XP, Centaur XPT, and Centaur CP Analysers. An in vitro diagnostic medical device (IVD).PSA Assay (100 Tests)Catalogue Number: 06574155Siemens Material Number (SMN): 10310292PSA Assay (500 Tests)Catalogue Number: 02676506Siemens Material Number (SMN): 10310293ARTG Number: 175243
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source