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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 Systemsee related information
Date Initiated by FirmAugust 04, 2006
Date PostedSeptember 23, 2006
Recall Status1 Terminated 3 on July 30, 2012
Recall NumberZ-1516-06
Recall Event ID 36181
510(K)NumberK971418 
Product Classification Immunoassay Analyzer - Product Code JJE
ProductADVIA 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/
Manufacturer
Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactMr. Steven Andberg
508-660-8540
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
ActionOn 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 CommerceDomestic - 101, Foreign - 153
DistributionWorldwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJE
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