BEUDAMED
    FDA Enforcement Class II Terminated

    Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462

    Recall: Z-1236-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1236-2019
    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

    Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462

    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: (Kit Lots ending in 317 or lower) 56683313 5/27/2019 70390317 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

    114 kits