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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA Centaur MultiDiluent 1

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  Class 2 Device Recall Siemens ADVIA Centaur MultiDiluent 1 see related information
Date Initiated by Firm July 25, 2012
Date Posted September 06, 2012
Recall Status1 Terminated 3 on November 04, 2015
Recall Number Z-2313-2012
Recall Event ID 62702
510(K)Number K031038  K083844  
Product Classification Test,natriuretic peptide - Product Code NBC
Product Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
Catalog Numbers:
2 Pack REF 07907174 (110312)
6 Pack REF 07293184 (110313).

Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
Code Information Lot # Expiry Date 2 Pack 76129 22 JUN 2012  77542 22 JUN 2012  78696 22 JUN 2012  80828 26 SEP 2012  80857 26 SEP 2012  81441 26 SEP 2012  82189 26 SEP 2012  83647 26 SEP 2012  84772 26 SEP 2012  86037 13 JAN 2013  86783 13 JAN 2013  88712 13 JAN 2013  90056 13 JAN 2013  91002 13 JAN 2013  93126 13 JAN 2013  6 Pack 76102 22 JUN 2012  76432 22 JUN 2012  77075 22 JUN 2012  78264 22 JUN 2012  79037 22 JUN 2012  81006 26 SEP 2012  82539 26 SEP 2012  83321 26 SEP 2012  84123 26 SEP 2012  85795 13 JAN 2013  86698 13 JAN 2013  88318 13 JAN 2013  89286 13 JAN 2013  90490 13 JAN 2013  91672 13 JAN 2013  93129 13 JAN 2013 
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		 Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for for BNP and TSH3 Ultra assays
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent an "URGENT DEVICE RECALL NOTICE" dated July 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Response Form was included for customers to complete and return via fax to (302) 631-7597. Contact your local Sales Representative for questions regarding this notice.
Quantity in Commerce 2 Packs = 15879 and 6 Packs = 7414
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Australia, Brazil, Chile, China, Croatia, Denmark, Ecuduar, Egypt,Guatemala, Hong Kong,India,Ireland, Israel,India, Japan,Korea, Mexico, Malyasia, Peru, Pakistan, Saudi Arabia,Singapore, Thailand,Uruguay, Viet Nam, and South Africa.
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 = NBC and Original Applicant = BAYER HEALTHCARE, LLC
510(K)s with Product Code = NBC and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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