BEUDAMED
    FDA Recall Terminated

    Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems

    Recall: Z-1077-2016 · Initiated February 4, 2016

    Recall

    Recall Number
    Z-1077-2016
    Event Number
    73263
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 4, 2016
    Posted
    March 8, 2016
    Terminated
    August 1, 2017
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems

    Reason

    ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay

    Action

    Siemens Healthcare issued an Urgent Medical Device Correction (UMDC) to all affected Siemens Healthcare Diagnostics customers in the United States on February 4, 2016 to be delivered to customers on February 5, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on February 4, 2016. These notices inform the customers of the lot to lot bias of Calibrator E with the ADVIA Centaur Testosterone assay and advise customers to move to Calibrator E kit lots ending in 44. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Correction. Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative

    Distribution

    Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC GT HK ID IE IL IN JP KR LK MM MX MY NI NP NZ PE PH PY SA SG TH TW UY VN ZA

    Quantity

    15224 (2-pack)