Siemens Dimension Vista 500 Analyzer Recall for Water Module Contamination
Siemens is recalling 5,373 Dimension Vista 500 analyzers because specific Millipore water purification modules may cause falsely elevated triglyceride results.
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 hazard is limited to erroneous test results (falsely elevated triglycerides) rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving diagnostic accuracy issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 5,373 units of the Dimension Vista 500 Analyzer, chemistry Model no. 10284473. The recall is due to the use of specific Millipore Water Purification Module Progard Pretreatment Packs, which may cause patient and quality control triglyceride results to be erroneously elevated as a result of contamination.
The affected units were distributed domestically nationwide and internationally. The recall involves specific Millipore lot numbers: F7MA50339, F7MA56608, F7NA62488, F8AA13966, F8AA93567, F8BA20457, F8BA35774, F8DA59251, F8HA64477, F8HA79819, F8HA91305, F8JA97876, and F8MA06374.
Healthcare facilities and users should stop using the affected water purification modules with the Dimension Vista Triglyceride assay and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Dimension Vista 500, Analyzer, chemistry Model no. 10284473
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 5,373
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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