BEUDAMED
    FDA Recall Terminated

    Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems.

    Recall: Z-1390-2012 · Initiated March 6, 2012

    Recall

    Recall Number
    Z-1390-2012
    Event Number
    61393
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    JFT
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 6, 2012
    Posted
    April 9, 2012
    Terminated
    June 26, 2015
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems.

    Reason

    Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims

    Action

    The firm, Siemens Healthcare, sent an "Urgent Field Safety Notice" via e-mail to all affected customers on March 6, 2012 in the United States and International. The Urgent Field Safety Notice describe the product, problem, and actions to be taken. The notice instructed the customers to perform daily calibration on all Cortisol reagent kits to maintain consistently accurate quality control and patient values; to complete and return the confirmation fax-back form 'Field Correction Effectiveness Check' via fax to the Technical Solutions Center at (302) 631-7597 and forward this notification to whomever they many have distributed this product. If you have any questions, contact Quality Engineer 5- Quality Systems and Compliance at 508-660-8540 or www.siemens.com/diagnostics.

    Distribution

    Worldwide distributed: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRALIA, BANGLADESH, BD, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, EGYPT, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, JAPAN, KOREA, MALAYSIA, MEXICO, NEW ZEALAND, PAKISTAN, PHILIPPINES, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, TAIWAN, THAILAND, URUGUAY, VENEZUELA, and VIETNAM.

    Quantity

    Total: 40023. 50 Test Kits = 21734;250 Test Kits= 15879;250 REF Test Kits= 2410