Use caution Medical device recall · FDA · Published October 19, 2023

Siemens epoc NXS Host Blood Analyzer: Erroneous Test Results Risk

Siemens Healthcare recalls epoc NXS Host Blood Analysis System with software versions 4.9.4 to 4.11.11 due to potential erroneous test results, risking misdiagnosis of hyperkalemia or hyperglycemia.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0601-2024Medical device Siemens Healthcare ›

Use caution until it’s fixed

Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.

Take action

Contact the company

Recalling firmSiemens Healthcare Diagnostics Inc2 Edgewater Dr · Norwood, MA 02062-4637

✎ GovInfoNow plain-language explainer

Siemens is recalling its epoc NXS Host Blood Analysis System because a software issue can cause printed test results to include incorrect analytes from previous tests. This could lead to missing hyperkalemia or hyperglycemia diagnoses, which might require urgent treatment. Read more at govinfonow.com/recall/57034-siemens-epoc-nxs-host-blood-analyzer-erroneous-test-results-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57034-siemens-epoc-nxs-host-blood-analyzer-erroneous-test-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0601-2024

Cite this page

“Siemens epoc NXS Host Blood Analyzer: Erroneous Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57034-siemens-epoc-nxs-host-blood-analyzer-erroneous-test-results-risk. Based on FDA recall #Z-0601-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0601-2024%22&limit=1).

The FDA announced on Oct. 19, 2023, that Siemens Healthcare Diagnostics Inc. is recalling the epoc NXS Host Blood Analysis System due to a software error causing erroneous printed results. The agency said the issue may lead to failure to diagnose hyperkalemia or inappropriate treatment for hyperglycemia.

How to tell if you have it

Brand: Siemens Healthcare
Product: epoc NXS Host Blood Analysis System
Siemens Material Numbers: 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517
Software versions: 4.9.4 to 4.11.11
UDI-DI codes: 00630414605760, 00630414606095, 00630414605821, 00630414605838, 00630414605678, 00630414605814, 00630414612447, 00630414631028
Units affected: 10,183 devices

The hazard

According to the FDA, a software problem causes erroneous results to be printed, saved, or transferred when the epoc NXS Host and Delete Blood Tests feature is enabled. The worst possible outcome may result in a failure to diagnose hyperkalemia due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to an erroneous glucose reading.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Beckman Coulter DxH Diluent Recall (Nov. 10, 2025) and Diagnostica Stago Asserachrom HPIA Kit Recall (Dec. 15, 2025).

How to tell if you have this one

Check the software version on your epoc NXS Host Blood Analysis System. The affected units have material numbers like 11413497 (EU), 11413475 (US), and software versions from 4.9.4 to 4.11.11.

Brand
Siemens Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Review the software version on your epoc NXS Host Blood Analysis System to determine if it is affected (versions 4.9.4 to 4.11.11).
Contact Siemens
Reach out to Siemens Healthcare for guidance on whether your system needs correction or update.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide. Global Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

Oct 19, 2023Firm started the recall
Dec 20, 2023FDA classified it Class II
Dec 27, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Siemens Healthcare recalls

Link to this recall

<a href="https://govinfonow.com/recall/57034-siemens-epoc-nxs-host-blood-analyzer-erroneous-test-results-risk">Siemens epoc NXS Host Blood Analyzer: Erroneous Test Results Risk (GovInfoNow)</a>

Where this comes from

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-0601-2024 (October 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0601-2024 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.