Z-1615-2016Class III

ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME...

Name: Z-1615-2016 ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-03-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-03-30 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for... on 2016-03-30. FDA classified it as Class III and gives the reason as "The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1615-2016
Classification: Class III
Status: Terminated
Initiated: 2016-03-30
Posted: 2016-05-06
Terminated: 2017-03-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This 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 identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
FDA root cause: Use error
Action: Siemens sent an Urgent Medical Device Correction letter dated March 2016, to all affected customers. The letter was sent to the US customers via Fed Ex beginning on March 30, 2016., and were e-mailed dated March 20, 2016, to regional countries for implementation outside the US. Field service personnel were sent a support bulletin describing the issue and instructing them how to manage customer questions. " Complete and return the Field Correction Effectiveness Check form attached to this letter within 30 days. " Please review this letter with your Medical Director. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (914) 524-2868.
Quantity in commerce: US: 442 units; Foreign: 3237 units
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1615-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1615-2016	Class III	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-06

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)