Lower riskMedical device recall · FDA · Published May 18, 2021
Siemens ADVIA Chemistry XPT System Recall: Incorrect Test Results Risk
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 ADVIA Chemistry XPT System Recall: Incorrect Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62531-siemens-advia-chemistry-xpt-system-recall-incorrect-test-results-risk. Based on FDA recall #Z-2014-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2014-2021%22&limit=1).
The FDA announced on May 18, 2021, that Siemens Healthcare Diagnostics, Inc. is recalling The ADVIA Chemistry XPT Chemistry System because the software may report erroneously elevated or depressed patient results without alerting users. This voluntary Class II recall affects 842 units distributed worldwide.
How to tell if you have it
Brand: Siemens Healthcare
Product: The ADVIA Chemistry XPT Chemistry System
Siemens Material Number (SMN): 10723034
Software Version: 1.4 or lower
UDI: 00630414595467
The hazard
The 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. This misalignment can cause an erroneously elevated or depressed patient result to be reported without alert on the test result.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls since June 7, 2017. Recent similar product recalls include the Siemens Atellica CH RCRP Test (Aug. 17, 2026), the Siemens Healthcare Syva EMIT 2000 Quinidine Assay (July 13, 2026), and the Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include the Siemens Healthineers Immulite 2000 Syphilis Screen Recall (July 13, 2026) and the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).
How to tell if you have this one
Check for the Siemens Material Number (SMN) 10723034 on the system. Affected units have software version 1.4 or lower with UDI 00630414595467.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on the system; affected units have version 1.4 or lower with UDI 00630414595467.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Connecticut, Florida, Maryland, Massachusetts, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2014-2021 (May 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2014-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.