Siemens recalls ADVIA Chemistry XPT systems with software versions 1.4 or lower that may report incorrect test results without alerts. Affected units include those with Siemens Material Number 10723034.
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
Siemens is recalling certain ADVIA Chemistry XPT systems that may report incorrect test results without warning. This could lead to inaccurate medical diagnoses if the system is used in clinical settings.
The system's default mixer failure detection setting may be incorrectly configured, causing test results to be reported without alerts. This could lead to inaccurate patient results if the system fails to detect a mixer issue.
Healthcare facilities using the ADVIA Chemistry XPT system with software versions 1.4 or lower (UDI 00630414595467) are most at risk. Patients receiving tests from these systems may be affected.
Check for the Siemens Material Number (SMN) 10723034 on the system. Affected units have software version 1.4 or lower with UDI 00630414595467.
Verify the software version on the system; affected units have version 1.4 or lower with UDI 00630414595467.
The ADVIA Chemistry XPT system with Siemens Material Number (SMN) 10723034.
Software versions 1.4 or lower with UDI 00630414595467.
Check for the Siemens Material Number (SMN) 10723034 and software version 1.4 or lower with UDI 00630414595467.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2014-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2014-2021 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
