Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
FDA Recall #Z-1235-2019 — Class II — December 7, 2018
Product Description
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Reason for Recall
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).
Recalling Firm
Siemens Healthcare Diagnostics, Inc — East Walpole, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1489 kits
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
Code Information
Lot Number/Exp. Date: kit lots ending in 317 and lower 72259303 12/13/2018 87903305 1/12/2019 94908307 2/11/2019 96439307 2/11/2019 16824309 3/14/2019 25822309 3/14/2019 28942311 4/27/2019 55978313 5/27/2019 70389317 6/29/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.