BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.

    Recall: Z-1240-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1240-2016
    Event ID
    73052
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    January 13, 2016
    Classification Date
    March 24, 2016
    Termination Date
    January 8, 2018
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.

    Reason

    The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.

    Code Info

    All lots

    Distribution

    Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.

    Quantity

    33604 units