Z-2715-2014Class II

ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use...

Name: Z-2715-2014 ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use...
Creator: Siemens Healthcare Diagnostics
Published: 2014-08-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-08-19 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics began a recall of ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed... on 2014-08-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2715-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-19
Posted: 2014-09-29
Terminated: 2018-05-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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
Root cause tag: software
FDA root cause: Software design
Action: Siemens 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 commerce: Domestic: 2771 units; Foreign: 7744 units
Distribution: Worldwide 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.
Product codes and lots: All serial numbers. Model Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015, 10326217, 10327008, 10327379, 10328250, 10328647, 10329364, 10330873, 10331013, 10332617, 10334139, 10334759, 10337512, 10337526, 10339677, 10340551, 10340737, 10341051, 10341110, 10361010, 10361011, 10361012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2715-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2715-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-29
Z-2716-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-29

Product code JJE

K041133Class IIModification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC / cleared 2004-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)