ADVIA Centaur PSA Assay 의 리콜

Recall

74917

Class 2

Z-2742-2016

2016-08-09

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148778

Communication provided to emphasize that the psa values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.

An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on July 29, 2016 to be delivered to customers on August 1, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 28, 2016. These emphasize that the prostate specific antigen (PSA) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy (e.g., the 2013 American Urological Association (AUA) Guidelines or the 2015 European Association of Urology (EAU)). These guidelines define biochemical recurrence of prostate cancer as a detectable or rising PSA value post-radical prostatectomy that is > or = 0.2 ng/mL (ug/L) with a second confirmatory level of > or = 0.2 ng/mL (ug/L). The communications also provide functional sensitivity from a recent study to give an expectation of precision at the low end of the assay.