BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

    Recall: Z-2742-2016 · Initiated August 9, 2016

    Recall

    Recall Number
    Z-2742-2016
    Event Number
    74917
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    LTJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 9, 2016
    Terminated
    January 6, 2020
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

    Reason

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

    Action

    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.

    Distribution

    Nationwide Albania Algeria Angola Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France Georgia Germany Great Britain Greece Hungary Iceland Iraq Italy Jordan Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Netherlands Norway Pakistan Poland Portugal Qatar Romania Russian Fed. Senegal Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey Unit.Arab Emir. Uzbekistan Vatican