Siemens Dimension Vista Lab Systems Recalled for Reagent Performance Issues
Siemens Healthcare Diagnostics is recalling Dimension Vista 500 and 1500 systems due to reagent probe performance decline that may affect patient and QC results.
What this means for you
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 text describes performance issues and discrepant results without reporting any specific patient injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Dimension Vista 500 and Dimension Vista 1500 Intelligent Lab Systems. These in vitro diagnostic devices are intended to duplicate manual analytical procedures, such as pipetting, mixing, heating, and measuring spectral intensities, to determine various analytes in human body fluids.
The recall was initiated due to customer complaints regarding discrepant flagged and un-flagged patient and quality control (QC) results. The reagent probe performance may decline more quickly than anticipated, which can affect assays with similar formulations when processed sequentially on the same reagent server.
A total of 1,949 units were distributed worldwide, including in the United States, Canada, and various countries in Europe, Asia, and the Middle East. Affected units are identified by Material Nos. 10284473, 10488224, 10444801, and 10444802. Users should contact Siemens Healthcare Diagnostics for further instructions on how to proceed with the recall.
The recalled product
- Product
- Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: 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 analyte
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,949
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 (4)
- Material Nos.: 10284473
- 10488224
- 10444801
- and 10444802
Distribution
Distribution scope not specified by the agency.
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