| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01005-1 |
| Product Name/Description |
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: 06574155
Siemens Material Number (SMN): 10310292
PSA Assay (500 Tests)
Catalogue Number: 02676506
Siemens Material Number (SMN): 10310293
ARTG Number: 175243 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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 https://www.tga.gov.au/alert/psa-assay-used-advia-centaur-systems . This action has been closed-out on 10/05/2017. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |