BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.

    Recall: Z-0754-2016 · Initiated December 29, 2015

    Recall

    Recall Number
    Z-0754-2016
    Event Number
    72968
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    MTF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 29, 2015
    Posted
    February 4, 2016
    Terminated
    November 29, 2019
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.

    Reason

    PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).

    Action

    An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on December 30, 2015 to be delivered to customers on December 31, 2015. An Urgent Field Corrective Action (UFCA) was sent out for distribution to all customers outside the United States on December 29, 2015. These notices identified the affected product, problem and actions to be taken. For questions customers were instructed to contact Siemens Customer Care Center or local Siemens technical support representative.

    Distribution

    Worldwide - US Nationwide including Puerto Rico, OUS: Albania, Algeria, Angola, Armenia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Iraq, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, Turkmenistan, Unit.Arab Emir., Vatican, AR, AU, BD, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IL, IN, JP, KR, LK, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN and ZA.

    Quantity

    55,754 kits