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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 1,407
Distribution
Part of a larger recall action
This product is one of 2 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.
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