The Recall Desk
HighFDA (Devices)·Z-0331-2022·Announced 2021-12-08

Siemens Dimension Vista 500 software issue affects test accuracy

Siemens is recalling 1,326 Dimension Vista 500 diagnostic devices worldwide due to incorrect default hemolysis, icterus, and lipemia indices that may affect test result accuracy.

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 an FDA Class II recall of a diagnostic device where software defects could affect test result accuracy and specimen quality assessment. No illnesses, injuries, or hospitalizations have been reported, but the device presents a risk-of-harm situation where inaccurate measurements could impact clinical decision-making.

Plain-English summary

The Siemens Dimension Vista 500 is an automated in-vitro diagnostic device used in clinical laboratories to analyze various analytes in human body fluids by duplicating manual procedures such as pipetting, mixing, heating, and measuring spectral intensities.

All software versions prior to 3.10.2 contain an incorrect default hemolysis, icterus, and lipemia (HIL) index for five specific assays. Hemolysis, icterus, and lipemia are conditions that can interfere with spectrophotometric measurements; an incorrect HIL index may result in inaccurate specimen quality assessment.

Approximately 1,326 units have been distributed worldwide, including throughout the United States and 20 countries in Europe, Asia, the Middle East, and Oceania. The recall affects all software versions prior to version 3.10.2, identified by GTIN numbers 00630414949581 and 00630414989556.

Siemens is providing a software update (version 3.10.2 or later) to correct the default HIL indices. Laboratories using the affected devices should update their software to ensure accurate specimen quality assessment and reliable test result reporting.

The recalled product

Product
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — In-vitro diagnostic / Laboratory equipment
Hazard
  • measurement-error
  • software-defect

Distribution

Distributed nationwide across the United States.

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