Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur AntiTg thyroid autoantibody test system.

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall ADVIA Centaur AntiTg thyroid autoantibody test system.see related information
Date Initiated by FirmDecember 07, 2018
Create DateApril 27, 2019
Recall Status1 Terminated 3 on April 27, 2020
Recall NumberZ-1233-2019
Recall Event ID 82521
510(K)NumberK012777 
Product Classification System, test, thyroid autoantibody - Product Code JZO
ProductSiemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
Code Information 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  
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information ContactSame
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
ActionSiemens 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 Commerce10673 kits
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = JZO
-
-