Z-2256-2016Class II

ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN...

Name: Z-2256-2016 ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-05-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-05-26 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781)... on 2016-05-26. FDA classified it as Class II and gives the reason as "Eight (8) issues were identified which may affect the results generated by the system software version". 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-2256-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-26
Posted: 2016-07-21
Terminated: 2018-06-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: 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: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Eight (8) issues were identified which may affect the results generated by the system software version.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On May 26, 2016, Siemens Healthcare Diagnostics Inc. distributed an Urgent Medical Device Correction notices to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers are advised to complete and return the Field Correction Effectiveness Check form within 30 days via fax to (312) 275-7795. For questions contact your local Siemens technical support representative.
Quantity in commerce: 446 units Total (3 domestically & 443 internationally)
Distribution: Worldwide Distribution - US Nationwide in the states of MD, MN, MS and the countries of Australia, Austria, Bangladesh, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guadeloupe, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Republic Korea, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E, United Kingdom & Vietnam.
Product codes and lots: none

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2256-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2256-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-21

Product code JLW

K141999Class IIAdvia Centaur TshSiemens Healthcare Diagnostics, Inc. / cleared 2015-04-22

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)