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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur CP System

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  Class 2 Device Recall ADVIA Centaur CP System see related information
Date Initiated by Firm August 04, 2006
Date Posted September 23, 2006
Recall Status1 Terminated 3 on July 30, 2012
Recall Number Z-1516-06
Recall Event ID 36181
510(K)Number K971418  
Product Classification Immunoassay Analyzer - Product Code JJE
Product ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.
Code Information All ADVIA Centaur CP systems using software versions 3.1 and 3.2.
Recalling Firm/
Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Mr. Steven Andberg
Manufacturer Reason
for Recall
Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID) field is left blank
FDA Determined
Cause 2
Software design
Action On 8/04/06, a Support Bulletin was e-mailed to all affected Bayer HealthCare LLC Branches worldwide in order to inform them of the issue and to provide them with instructions for this 'field correction' until the new software version is issued. A Customer Bulletin and Confirmation Form (FaxBack) were prepared and sent to the affected Bayer Healthcare LLC Branches on 8/04/06 for communication with the affected customers worldwide.
Quantity in Commerce Domestic - 101, Foreign - 153
Distribution Worldwide
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 = JJE and Original Applicant = CHIRON DIAGNOSTICS CORP.