Recall Z-0645-2007 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics
ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device: Under 21 CFR, Part 862.2160, the ADVIA Centaur CP is a discrete photometric chemistry analyzer for clinical use and is classified as a Class I (general control) device. --- The ADVIA Centaur CP is part of Bayer's Immunochemistry analyzer family, which also includes the ADVIA C
| Date | Mar 22, 2007 (initiated Nov 9, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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 ac |
| Quantity | 306 units: 101- Domestic, 205 - Foreign |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER Chiron Diagnostics Corp., Jul 17, 1997 |