ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device:
FDA device recall Z-0645-2007 · posted 2007-03-22 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics
- Reason for recall
- Firm received complaints for signal 2 & 4 errors, and shifts in Relative Light Units (RLU). Investigations showed that the On-Board Stability (OBS) of the acid & base reagents may be compromised after 4 days after installation onto the Centaur CP system due to evaporation.
- Action taken
- A Support Bulletin was sent by e-mail to all affected Bayer HealthCare LLC Branches on 11/09/06 in order to inform them of the issue and to provide them with instructions for this field correction. Two Customer Bulletins were prepared and sent by e-mail to Bayer HealthCare LLC Branches on 11/09/06 both in the US and outside the US for communication with the affected customers. The first bulletin advised customers of the problem and the corrective action. A Confirmation (Fax-back) Form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. The second Customer Bulletin describes an optional alternative mitigation, which requires a Bayer representative to go to the customer site to implement.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 306 units: 101- Domestic, 205 - Foreign
- Distribution
- Worldwide
- Date initiated
- 2006-11-09
- Date posted
- 2007-03-22
- 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 |