Siemens Dimension Vista 1500 Recalled for Potential Sample Contamination
Siemens is recalling Dimension Vista 1500 instruments due to a software issue that may cause sample contamination if tests are manually cancelled during aliquoting.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination without confirmed adverse events.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,628 units of the Dimension Vista 1500, Model No. 10444801, an in vitro diagnostic device used to analyze human body fluids. The recall involves instruments running Dimension Vista software versions 3.7 and 3.8.1, which were distributed nationwide and worldwide.
The recall is due to a software issue that may result in aliquot well contamination. If an operator manually cancels a test for calibration, quality control, or patient samples while the instrument is aliquoting, the device may continue to deliver the cancelled sample or vial contents to the aliquot well. This can lead to future samples being assigned to the same well and becoming contaminated, or overflow may occur, potentially contaminating surrounding wells.
The issue only occurs when an operator manually cancels a test while the instrument is in the process of aliquoting the sample. No specific instructions for consumers are provided in the source text, but the recall is limited to the specific software versions and model number identified.
The recalled product
- Product
- Dimension Vista 1500, Model No. 10444801 an 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 fluids.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 1,628
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 (1)
- Dimension Vista software versions 3.7 and 3.8.1
Distribution
Distributed nationwide across the United States.
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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