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
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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/ Manufacturer |
Siemens Healthcare Diagnostics 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact | Mr. 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 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = JJE
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