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U.S. Department of Health and Human Services

Class 2 Device Recall SiemensADVIA Centaur Calbarator C

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  Class 2 Device Recall SiemensADVIA Centaur Calbarator C see related information
Date Initiated by Firm October 09, 2012
Date Posted October 24, 2014
Recall Status1 Terminated 3 on June 18, 2015
Recall Number Z-0129-2015
Recall Event ID 69449
510(K)Number K110736  
Product Classification Ferritin, antigen, antiserum, control - Product Code DBF
Product ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic)

Catalog Number: 06567787 (6 pack)
Code Information Lot numbers: 82069A22 Exp Date: 01/19/2013 82946A22  84494A22  85340A22  85804B22 87430B22 90884B22 95232A23 Exp. Date: 10/16/2013 95589A23 96012A23
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		 Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens issued an Urgent Field Safety Notice via e-mail to all US customers affected on October 9, 2012. This notice informs the customer of the Field Correction and the actions that need to be taken. The Urgent Field Safety Notice instructs customers that upon receipt of Calibrator C Lots ending in 25 and higher (Cal C lots CC25LA and higher and Cal C lots CC25HA and higher), discontinue use of the Calibrator C lots ending in 22 and 23 with the ADVIA Centaur Ferritin assay when used on the ADVIA Centaur CP system. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Further questions please call (508) 668-5000
Quantity in Commerce 2440 kits
Distribution Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, 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 = DBF and Original Applicant = Siemens Healthcare Diagnostics Inc.
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