ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.
This recall has been terminated (originally issued September 23, 2006).
- Company
- Siemens Healthcare Diagnostics
- Recall Initiated
- August 4, 2006
- Posted
- September 23, 2006
- Terminated
- July 30, 2012
- Recall Number
- Z-1516-06
- Quantity
- Domestic - 101, Foreign - 153
- Firm Location
- Tarrytown, NY
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide
Lot / Code Info
All ADVIA Centaur CP systems using software versions 3.1 and 3.2.
Root Cause
Software design
Action Taken
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.