Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2014-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use.

Product Classification:

Class II

Date Initiated: May 18, 2021

Date Posted: July 14, 2021

Recall Number: Z-2014-2021

Event ID: 88086

Reason for Recall:

ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result

Status: Terminated

Product Quantity: 842 units

Code Information:

Software version: 1.4 or lower UDI - 00630414595467

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, MA, MD, MI, MN, NY, OH, PA, TX and the countries of Australia, Bahrain, Brazil, Canada, Chile, Croatia, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Portugal, Republic Korea, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated