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.
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.
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.
When the Delete Blood Tests feature is enabled, the system may print results that include analytes from previous tests instead of the current patient's test. This could cause a false low potassium reading, leading to missed hyperkalemia diagnosis, or a false high glucose reading, risking inappropriate hyperglycemia treatment.
Lab users who own or operate the epoc NXS Host Blood Analysis System with software versions 4.9.4 to 4.11.11 are affected. Patients relying on this system for blood tests may be at risk of misdiagnosis.
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.
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).
Reach out to Siemens Healthcare for guidance on whether your system needs correction or update.
The system may print test results that include analytes from previous tests, potentially causing missed hyperkalemia or hyperglycemia diagnoses.
Check the software version (4.9.4 to 4.11.11) and material numbers listed in the recall notice.
The recall does not specify a fix; users must contact Siemens for guidance on corrections or updates.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0601-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0601-2024 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.
