Siemens epoc NXS Blood Analysis System Software Causes Erroneous Test Results
Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with potential for serious patient harm through diagnostic errors. The defect could prevent diagnosis of life-threatening hyperkalemia or lead to inappropriate treatment decisions, though no illnesses or injuries have been reported to date.
Plain-English summary
Siemens Healthcare Diagnostics Inc. has recalled the epoc NXS Host Blood Analysis System due to a software defect affecting software versions 4.9.4 through 4.11.11. The affected product is distributed nationwide in the US and globally, with approximately 10,183 devices involved.
A software problem causes erroneous test results to be generated when the Delete Blood Tests feature is enabled. While the results are correct at the time of initial testing, the printed, saved, or transmitted results may incorrectly include analytes (blood components) from previous patient or quality control tests that were not selected for the current test.
This defect could lead to serious patient harm, including failure to diagnose hyperkalemia (dangerously high potassium levels) due to a falsely low reading, or inappropriate treatment of hyperglycemia (high blood sugar) based on an erroneous glucose result. Healthcare facilities and laboratories using this blood analysis system should be aware of this potential risk.
The recalled product
- Product
- epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 10,183
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics Inc
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · erroneous results
See all →- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighLaboratory automation recalled over sample tubes with mismatched labels
FDA (Devices) · 2025-12-03
- HighLaboratory automation recalled over unlabelled or mismatched secondary sample tubes
FDA (Devices) · 2025-12-03
- HighBlood lead test kits recalled over mislabeled calibration buttons
FDA (Devices) · 2025-12-03
Similar recalls
- HighSiemens epoc blood analyzer software assigns incorrect patient names
FDA (Devices) · 2025-01-01
- HighSiemens Blood Analysis Device Recalled Over Patient Name Mix-up Software Defect
FDA (Devices) · 2025-01-01
- HighSiemens epoc Blood Analysis System Recalled for Patient Identification Software Error
FDA (Devices) · 2025-01-01
- HighBlood Analysis System Recalled Due to Patient Name Assignment Software Error
FDA (Devices) · 2025-01-01
- HighBlood Analysis System Software Malfunction May Assign Incorrect Patient Names
FDA (Devices) · 2025-01-01
- HighBlood Analysis System Software Error Can Assign Wrong Patient Name
FDA (Devices) · 2025-01-01