BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398

    Recall: Z-1233-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1233-2019
    Event ID
    82521
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2019
    Initiation Date
    December 7, 2018
    Classification Date
    April 26, 2019
    Termination Date
    April 27, 2020
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398

    Reason

    Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).

    Code Info

    Lot Number/Exp. Date: 68748302 12/13/2018 68749302 12/13/2018 83577304 1/12/2019 88637304 1/12/2019 5610306 2/11/2019 96436306 2/11/2019 19097308 3/14/2019 31866310 4/27/2019 45386310 4/27/2019 55627312 5/27/2019 69208316 6/29/2019 73000316 6/29/2019

    Distribution

    Nationwide Foreign: Belgium¿¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Turkey¿¿¿¿¿¿¿ BOGOTA QUARRY BAY, HONG KONG YANGON SANTIAGO DE CHILE MONTEVIDEO BUENOS AIRES LIMA JOINVILLE, SC, BRAZIL Selangor Darul Ehsan Dhaka Ha Noi City Gurgaon, Haryana Hanoi-Hoangmai ASUNCION SHANGHAI Seoul 120 SINGAPORE RIYADH 11411 TAIPEI R.O.C. QUITO HUNTINGWOOD, NEW SOUTH WALES ZAPOPAN Ho Chi Minh-District 3 Huaykwang, Bangkok RIYADH SAN JOSE CHIBA LAVAL HO CHI MINH CITY MANAGUA Gurgaon, Haryana

    Quantity

    10673 kits