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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica IM AntiThyroglobulin

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  Class 2 Device Recall Atellica IM AntiThyroglobulin see related information
Date Initiated by Firm December 07, 2018
Create Date April 27, 2019
Recall Status1 Terminated 3 on April 27, 2020
Recall Number Z-1236-2019
Recall Event ID 82521
510(K)Number K012777  
Product Classification System, test, thyroid autoantibody - Product Code JZO
Product Atellica IM aTG (500 test kit)
Siemens Material Number (SMN): 10995462
Code Information Lot Number/Exp. Date: (Kit Lots ending in 317 or lower) 56683313 5/27/2019 70390317 6/29/2019 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact Same
508-668-5000
Manufacturer 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).
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens issued Urgent Medical Device Corrections, to Siemens Healthcare Diagnostics customers in the United States on December 7, 2018 delivered to customers on December 10, 2018. Urgent Field Safety Notices sent out to the country organizations on December 7, 2018 for distribution to customers outside the United States. These letters inform customers that Siemens Healthcare Diagnostics identified a bias with the affected lots of ADVIA Centaur¿ aTG and Atellica IM¿ aTG and action to take and resolution of the issue with new lots of the reagents. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce 114 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JZO and Original Applicant = BAYER CORP.
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