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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm July 17, 2012
Date Posted August 20, 2012
Recall Status1 Terminated 3 on November 22, 2013
Recall Number Z-2228-2012
Recall Event ID 62640
510(K)Number K112343  
Product Classification Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
Product Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack
Reference Number 10492493

Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, citrate) using the ADVIA Centaur and ADVIA Centaur XP systems as an aid in the diagnosis of syphilis
Code Information US Lot Number/Exp. Date 85456003 2012-10-13; 86036003 2012-10-13; 87129003 2012-10-13; 88440003 2012-10-13; 90054004 2013-04-09; 90422004 2013-04-09. Outside the US: Kit lots, 77749002, 80615003, 82640003, 84120003, 85456003, 86036003, 87129003,88440003,90054004,90422004. 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
508-668-5000
Manufacturer Reason
for Recall		 Syphilis Assay Interference with HBsAg Assay
FDA Determined
Cause 2		 Component design/selection
Action Siemens Healthcare sent Urgent Device Recall Notice letters dated July 2012 via e-mail to all affected customers inside and outside the US. The letters identifed the affected product, reason for voluntary recall and risk to health. The letters provided actions to be taken by the customers and if there are any remaining inventory of the affected product, follow the guidelines outlined. Customers were instructed to complete and return the Field Correction Effectiveness Check form. For questions contact your local Technical Support Provider or Distributor.
Quantity in Commerce 2050 Kits
Distribution Worldwide Distribution - US Nationwide and the countries of: Foreign: Brazil, China, Denmark, Hong Kong, Malaysia, and New Zealand Viet Nam
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 = LIP and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.
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