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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur XP Immunoassay System

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 Class 2 Device Recall ADVIA Centaur XP Immunoassay Systemsee related information
Date Initiated by FirmAugust 19, 2014
Date PostedSeptember 29, 2014
Recall Status1 Terminated 3 on May 22, 2018
Recall NumberZ-2716-2014
Recall Event ID 69084
510(K)NumberK041133 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Code Information All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 
FEI Number 2432235
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
Manufacturer Reason
for Recall		The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the LIS is merged with the next order. This issue can occur when the LIS data buffer on the ADVIA Centaur system becomes full
FDA Determined
Cause 2		Software design
ActionSiemens sent an Urgent Medical Device Correction Letter dated August 19, 2014, via Fed Ex to US customers and via email to regional countries for implementation outside the US (OUS). The letter identified the product the problem and the action needed to be taken by the customer. The letters inform the customers of the issue and specific actions to be taken if the instrument is interfaced to an LIS system that transmits patient demographics with each order. Field service personnel were sent a support bulletin describing the issue and instructing them how to deal with customer questions. Please complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative. Please fax this completed form to the Customer Care Center at (302) 631-7597. If you have any questions, contact your local Siemens technical support representative
Quantity in CommerceDomestic: 2771 units; Foreign: 7744 units
DistributionWorldwide Distribution including the United States., and the countries of Argentina, Austria, Australia, Bahrain, Bangladesh, Belgium, Belgrade, Brazil, Botswana, Canada, Chile, China, Colombia, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Georgia, Great Britain, Hungary, Indonesia, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kazakhstan, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, New Caledonia, Netherlands, Norway, New Zealand, Pakistan, French Polynesia, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, Vatican, Venezuela, Vietnam, Yemen and Zimbabwe.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JJE
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