Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2088-2013·Announced 2013-09-04

Siemens Dimension Vista Systems Recalled for Potential Sample Dispensing Error

Siemens is recalling Dimension Vista 500 and 1500 systems due to a rare software issue that may cause samples to be dispensed into previously used wells.

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, but the source explicitly states the defect occurs under 'specific rare conditions' and reports no illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems equipped with software versions 3.5.1 and 3.6. The recall involves 1,937 units distributed worldwide, including the United States and numerous international markets.

The recall is issued because, under specific rare conditions requiring a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a quality control (QC) or calibrator product. This error could occur if two samples are dispensed into the same aliquot well, potentially compromising the integrity of the test results.

Healthcare facilities and laboratories using these systems should contact Siemens Healthcare Diagnostics for instructions on the field correction. The source text does not report any illnesses or injuries associated with this defect.

The recalled product

Product: Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: sample-contamination
software-defect
Affected units: 1,937

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 (2)

Dimension Vista 500 Siemens material numbers: 10284473 (domestic)
and 10488224 (international)

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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