ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.
FDA device recall Z-1516-06 · posted 2006-09-23 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics
- 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
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- Domestic - 101, Foreign - 153
- Distribution
- Worldwide
- Date initiated
- 2006-08-04
- Date posted
- 2006-09-23
- Date terminated
- 2012-07-30
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER (K971418) | Chiron Diagnostics Corp. | 1997-07-17 |