The Recall Desk
HighFDA (Devices)·Z-0735-2025·Announced 2025-01-01

Blood analyzer system recalled for patient name assignment software error

Siemens recalled its epoc NXS Host blood analyzer due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis or 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: This is a risk-of-harm medical device where patient misidentification could lead to clinical error, but no illnesses or injuries have been reported. FDA Class II classification with a theoretical hazard places this in the High severity category per the rubric.

Plain-English summary

Siemens Healthcare Diagnostics is recalling the epoc NXS Host, an in vitro diagnostic blood analysis system used by trained medical professionals in laboratories and at point-of-care settings. Approximately 3,011 units have been distributed nationwide and internationally.

The recall is due to a software malfunction in Version 4.14.9 that can incorrectly assign a patient's name to a blood measurement result. This error occurs when specific criteria are met and the device user does not ensure verification of the correct patient name before accepting the result.

The software defect poses a patient safety risk. If the wrong patient information is saved with a test result, a clinician relying on that information could make decisions based on incorrect patient data, resulting in misdiagnosis or inappropriate treatment.

Users of the epoc NXS Host should verify patient identification information before finalizing test results to ensure measurements are correctly attributed to the intended patient.

The recalled product

Product
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); 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 capi
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • patient-misidentification
  • software-malfunction
  • misdiagnosis-risk

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: 11413497
  • UDI-DI: 00630414605760 Software Version Number: 4.14.9.

Distribution

Distributed nationwide across the United States.

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