Z-1553-2014Class II

ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA...

Name: Z-1553-2014 ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA...
Creator: Siemens Healthcare Diagnostics
Published: 2014-02-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-02-18 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics began a recall of ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur... on 2014-02-18. FDA classified it as Class II and gives the reason as "Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1553-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-18
Posted: 2014-05-13
Terminated: 2017-03-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.
Root cause tag: design
FDA root cause: Device Design
Action: On February 18, 2014 Siemens Healthcare Diagnostics distributed Urgent Medical Device Correction notices to their customers via courier service (Urgent Medical Device Correction/). Upon receipt of the communication, customers are asked to follow "Actions to be Taken by the Customer". If the cover is unable to stay partially raised, immediately contact your Siemens technical support representative to arrange for a service. Complete and return the Field Correction Effectiveness Check attached to this letter within thirty (30) days by faxing to (302) 631-7597. Customers with questions should contact their Siemens technical support representative.
Quantity in commerce: 5,900 units total (1,679 domestically & 4,221 internationally)
Distribution: Nationwide and internationally
Product codes and lots: All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1553-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1553-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06

Product code JJE

K971418Class IIChiron Diagnostics Automated Chemiluminescence System (Asc) Centaur AnalyzerChiron Diagnostics Corp. / cleared 1997-07-17

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)