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 Centaur and the ACS:180. Based on FDA guidance for deciding when regulatory filings are warranted for Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.