The Recall Desk
HighFDA (Devices)·Z-0601-2024·Announced 2023-12-27

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.

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: 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
Category
Medical Device — Blood Analysis System
Hazard
  • erroneous-results
  • wrong-patient-data
  • misdiagnosis

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 category