Siemens Healthcare Diagnostics ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.
Brand
Siemens Healthcare Diagnostics
Lot Codes / Batch Numbers
All ADVIA Centaur CP systems using software versions 3.1 and 3.2.
Products Sold
All ADVIA Centaur CP systems using software versions 3.1 and 3.2.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001. due to Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient n. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026