The Recall Desk
HighFDA (Devices)·Z-0330-2022·Announced 2021-12-08

Dimension Vista 1500 Diagnostic Device: Incorrect HIL Index Defaults

Siemens is recalling 1,407 Dimension Vista 1500 diagnostic devices worldwide due to incorrect default Hemolysis, Icterus, and Lipemia (HIL) index values affecting five assays.

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 device recall involving incorrect default values for diagnostic quality indices that could affect test accuracy. While no illnesses or injuries have been reported, the potential for patient harm exists if incorrect HIL indices cause acceptance or rejection of compromised samples, meeting the criterion for risk-of-harm products.

Plain-English summary

Siemens Healthcare Diagnostics is recalling the Dimension Vista 1500 in-vitro diagnostic device due to incorrect default values for Hemolysis, Icterus, and Lipemia (HIL) indices in five assays. The affected devices have software versions prior to 3.10.2.

The HIL indices are used to identify samples that may have hemolysis (red blood cell destruction), icterus (jaundice), or lipemia (elevated lipids), which can interfere with test results. Incorrect default values for these indices could affect the accuracy of diagnostic measurements and sample quality assessment.

Approximately 1,407 devices have been distributed worldwide, including throughout the United States and internationally to Germany, Spain, France, Italy, Canada, Netherlands, Japan, Portugal, Australia, Czech Republic, Austria, Denmark, Slovenia, Belgium, Slovakia, Qatar, Saudi Arabia, South Korea, and Switzerland.

Healthcare facilities and laboratories using affected devices should update the software to version 3.10.2 or later. Contact Siemens Healthcare Diagnostics for instructions on obtaining and installing the software update.

The recalled product

Product
Dimension Vista 1500 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: 10444801(US) and 10444802 (OUS)
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Diagnostic / Laboratory
Hazard
  • measurement-error
  • diagnostic-inaccuracy

Distribution

Distributed nationwide across the United States.

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