Blood Analysis System Recalled Due to Patient Name Assignment Software Error
Siemens is recalling the epoc NXS Host blood analysis system due to a software defect that can incorrectly assign patient names to test results, potentially causing misdiagnosis and mistreatment.
What this means for you
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: The recall involves a medical device with a software defect that has the potential to cause patient harm through misdiagnosis and mistreatment. However, no illnesses or injuries have been reported, and the hazard is theoretical rather than documented, placing it in the High severity category.
Plain-English summary
Siemens Healthcare Diagnostics is recalling the epoc NXS Host blood analysis system (Siemens Material Number 11413475, Software Version 4.14.9), an in vitro diagnostic device used by medical professionals for blood testing. Approximately 6,738 units have been distributed nationwide and internationally.
The recall is due to a software malfunction that, under specific conditions, can incorrectly assign a patient's name to a blood test result. This error occurs only if the user fails to verify the correct patient name before accepting the result. If wrong patient information is saved with the test result, it could lead to misdiagnosis and mistreatment by clinicians who rely on the incorrect patient data.
Healthcare facilities and healthcare providers using the epoc NXS Host should contact Siemens Healthcare Diagnostics for information on correcting or replacing affected devices.
The recalled product
- Product
- epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capill
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 6,738
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 (2)
- Siemens Material Number: 11413475
- UDI-DI: 00630414606095 Software Version Number: 4.14.9.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- 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
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · patient misidentification
See all →- SevereGE Healthcare MAC VU360 Electrocardiograph Software Recall
FDA (Devices) · 2026-08-12
- HighBar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk
FDA (Devices) · 2026-08-05
- HighGE Healthcare AW Server Radiological Image Processing System Software Defect
FDA (Devices) · 2026-07-01
- 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