Z-1516-06

ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001

Name: Z-1516-06 ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001
Creator: Siemens Healthcare Diagnostics
Published: 2006-08-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-08-04 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics began a recall of ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001 on 2006-08-04. The reason FDA records is "Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the 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-1516-06
Status: Terminated
Initiated: 2006-08-04
Posted: 2006-09-23
Terminated: 2012-07-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID) field is left blank
Root cause tag: software
FDA root cause: Software design
Action: On 8/04/06, a Support Bulletin was e-mailed to all affected Bayer HealthCare LLC Branches worldwide in order to inform them of the issue and to provide them with instructions for this 'field correction' until the new software version is issued. A Customer Bulletin and Confirmation Form (FaxBack) were prepared and sent to the affected Bayer Healthcare LLC Branches on 8/04/06 for communication with the affected customers worldwide.
Quantity in commerce: Domestic - 101, Foreign - 153
Distribution: Worldwide
Product codes and lots: All ADVIA Centaur CP systems using software versions 3.1 and 3.2.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)