Z-2663-2014Class II

ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507...

Name: Z-2663-2014 ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507...
Creator: Siemens Healthcare Diagnostics
Published: 2014-08-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-08-13 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics began a recall of ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213... on 2014-08-13. FDA classified it as Class II and gives the reason as "The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue...". 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-2663-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-13
Posted: 2014-09-18
Terminated: 2017-05-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 10327836, 10328940, 10329339, 10336292, 10338631, 10364455, 10388696, 10471899 --- For in vitro diagnostic use This immunoassay system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems. Pushing the sample racks may cause misreads of Sample IDs (SID) if the sample rack loading instructions are not followed exactly as described in the ADVIA Centaur or ADVIA Centaur XP Operators Guide.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: The firm, Siemens, sent "Urgent Medical Device Correction" Letters (dated 8/13/2014) to their consignees/customers informing them of the issue and actions to be taken. Field service personnel were sent a Support Bulletin describing the issue and instructing them how to deal with customer questions. The UFSN must be used by customers as an addendum to the system operating instructions until further notice. The consignees/customers were also instructed to review this letter with your Medical Director; complete and return the attached FIELD CORRECTION EFFECTIVENESS CHECK within 30 days via fax to the Customer Care Center at (302) 631-7597; retain the letter with your laboratory records and forward the letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center, your local Siemens technical support representative and/or call 914-524-2868.
Quantity in commerce: 10,515 (Domestic: 2771; Foreign: 7744) in total
Distribution: Worldwide Distribution: US (nationwide) and 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, Kazakstan, 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2663-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2662-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-18
Z-2663-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-18

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)