Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2256-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 26, 2016

Date Posted: July 27, 2016

Recall Number: Z-2256-2016

Event ID: 74309

Reason for Recall:

Eight (8) issues were identified which may affect the results generated by the system software version.

Status: Terminated

Product Quantity: 446 units Total (3 domestically & 443 internationally)

Code Information:

none

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated