Siemens Dimension Vista 1500 Analyzer Recall Due to Water Module Contamination
Siemens is recalling 5,373 Dimension Vista 1500 analyzers because specific water purification modules may cause falsely elevated triglyceride 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, and the hazard involves erroneous test results rather than direct physical injury or a high-risk pathogen, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 5,373 units of the Dimension Vista 1500 Analyzer, chemistry Model no. 10444801. The recall is due to the use of Millipore Water Purification Module Progard Pretreatment Packs with the Dimension Vista Triglyceride assay, which may result in erroneously elevated patient and quality control triglyceride results due to contamination.
The affected products 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 should stop using the affected water purification modules with the triglyceride assay and contact Siemens Healthcare Diagnostics for further instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
- 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · contamination
See all →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02