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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur CP System

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 Class 2 Recall
ADVIA Centaur CP System
see related information
Date Posted March 22, 2007
Recall Status1 Open
Recall Number Z-0645-2007
Recall Event ID 37390
Premarket Notification
510(K) Number
K971418 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product 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 device modifications, as well as, the FDA Instrument Family and Replacement Reagent Policy Guidance, Bayer determined that the changes associated with the ADVIA Centaur CP did not affect the safety and effectiveness of the predicate device (ACS:180) and therefore no device modification 510(k) was warranted. The ADVIA Centaur CP instrument uses the same reagents as the ADVIA Centaur. The ACS:180 was cleared by FDA under 510(k) # K902336, and the ADVIA Centaur was cleared by FDA under 510(k) # K971418. The ADVIA Centaur CP system was released for sale in November 2005 and distribution of these systems began at that time. All ADVIA Centaur CP Systems are impacted. There is no expiration date for these systems.
Code Information All serial numbers of the ADVIA Centaur CP System are impacted by this ''field correction''.
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown, New York 10591-5005
For Additional Information Contact Mr. Steven Andberg
508-660-8540
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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 action. The second Customer Bulletin describes an optional alternative mitigation, which requires a Bayer representative to go to the customer site to implement.
Quantity in Commerce 306 units: 101- Domestic, 205 - Foreign
Distribution Worldwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = CHIRON DIAGNOSTICS CORP.
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