Siemens Dimension Vista 500 Recalled for Sample Contamination Risk
Siemens is recalling Dimension Vista 500 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 harm without confirmed adverse events.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,649 Dimension Vista 500 in vitro diagnostic devices, model no. 10284473. These devices are used to determine analytes in human body fluids by duplicating manual analytical procedures. The recall involves units 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 a patient sample while the instrument is aliquoting, the device may continue to deliver the 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 that contaminates surrounding wells.
This issue only occurs when an operator manually cancels a test while the instrument is in the process of aliquoting the sample. Users of these devices should contact Siemens Healthcare Diagnostics for further instructions on how to address the software issue.
The recalled product
- Product
- Dimension Vista 500, model no. 10284473 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
- 1,649
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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