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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur TnIUltra Assay

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  Class 2 Device Recall ADVIA Centaur TnIUltra Assay see related information
Date Initiated by Firm June 07, 2007
Date Posted June 05, 2008
Recall Status1 Terminated 3 on August 28, 2012
Recall Number Z-0580-2008
Recall Event ID 44725
510(K)Number K053020  
Product Classification in vitro diagnostic (Troponin) - Product Code MMI
Product ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591
Code Information All lots. 500 tests: Part/Catalog #02790309, and 100 tests: Part/Catalog # 02789602.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions Diagnostics
511 Benedict Avenue
Tarrytown NY 10591-5005
For Additional Information Contact Steven Andberg
508-359-3825
Manufacturer Reason
for Recall		 Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.
FDA Determined
Cause 2		 Material/Component Contamination
Action Two Support Bulletins (078N0361-01 & 078N0361-02) were sent by e-mail to all affected Siemens Diagnostics Branches to inform them of this issue. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. Two Customer Bulletins (078D0647-01 & 078D0651-01) were sent by e-mail to the Siemens Diagnostics Branches for communication with the affected customers. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. These bulletins state that if a false positive is suspected, the sample should be diluted and retested.
Quantity in Commerce Domestic: 31,497 kits; Foreign: 27,321 kits
Distribution Worldwide Distribution - USA, Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela
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 = MMI and Original Applicant = BAYER HEALTHCARE, LLC
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