BEUDAMED
    FDA Enforcement Class II Terminated

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    Recall: Z-2149-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2149-2014
    Event ID
    68665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2014
    Initiation Date
    June 23, 2014
    Classification Date
    August 5, 2014
    Termination Date
    March 31, 2016
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.

    Reason

    Complaints of failed calibration.

    Code Info

    Lot# 38479172 and 39181172

    Distribution

    Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada, Albania, Argentina, Australia, Bosnia Herzeg., Brazil, Chile, Colombia, Egypt, Georgia, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Japan, Kazakhstan, Lebanon, Malaysia, New Caledonia, Oman, P.R. China, Pakistan, Philippines, Qatar, Rep. of Yemen, Republic Korea, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, Taiwan, Thailand, U.A.E., Ukraine, Venezuela, Vietnam, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

    Quantity

    1,191 kits