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 us
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling 842 units of the ADVIA Chemistry XPT Chemistry System with software versions 1.4 or lower worldwide. The recalled systems may produce erroneously elevated or depressed patient test results without alerting the operator due to misalignment between the system settings and customer expectations regarding the default mixer failure detection setting. This could lead to inaccurate patient results being reported.
The affected devices are distributed across the United States in California, Colorado, Connecticut, Florida, Massachusetts, Maryland, Michigan, Minnesota, New York, Ohio, Pennsylvania, and Texas, as well as internationally in countries including Australia, Brazil, Canada, Chile, Denmark, France, Germany, India, Italy, the Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, South Korea, and Spain, among others. The recall record does not specify a remedy or action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: 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, Spa Quantity: 842 units Lot/code info: Software version: 1.4 or lower UDI - 00630414595467
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.