Siemens Dimension Vista Diagnostic Vials Recalled for Volume Error
Siemens is recalling Dimension Vista 500 and 1500 reloaded vials because they may incorrectly reset to full volume, potentially affecting diagnostic accuracy.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential software error affecting diagnostic accuracy without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 776 units of Dimension Vista(R) 500 and Dimension Vista(R) 1500 reloaded Vista vials. This recall is limited to systems using software versions 3.4 and 3.5.1. The affected products are diagnostic devices intended to determine a variety of analytes in human body fluids.
The recall is due to a potential software issue where the vial volume of "in use" Vista calibrators, controls, or sample diluent may incorrectly revert to full volume when removed and reloaded. This error could impact the accuracy of the diagnostic results.
The affected units were distributed nationwide in the USA and internationally to Canada. Siemens Material Numbers 10284473 (Dimension Vista 500) and 10444801 (Dimension Vista 1500) are involved. Users should contact Siemens Healthcare Diagnostics for further instructions on how to proceed.
The recalled product
- Product
- Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 776
Distribution
Distributed nationwide across the United States.
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