Siemens Recalls Dimension Vista BUN Reagent Cartridges for Inaccurate Results
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista BUN Flex reagent cartridges because they may produce inaccurate patient or quality control 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. The hazard involves inaccurate diagnostic results, which is a significant quality issue but does not involve a direct physical injury mechanism like fire or choking, nor are there reported illnesses or fatalities in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 18,668 units of Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridges. The affected lots are 15215AE, 15243BB, 15264BA, 15299BB, 15300BA, and 15341AC. These products are in vitro diagnostic tests used to measure urea nitrogen in human serum, plasma, and urine on the Dimension Vista System.
The recall was initiated because the company determined that the affected cartridges may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagent cartridges manufactured from specific mold cavities.
The affected products were distributed worldwide, including nationwide distribution in the United States (including Puerto Rico) and to various countries in Europe, Asia, and the Americas. Users of the Dimension Vista System should check their inventory for the specific lot numbers listed and stop using the affected cartridges.
The recalled product
- Product
- Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 18,668
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 (7)
- Device Listing # D011374
- Lot # 15341AC
- 15320BB
- 15300BA
- 15299BB
- 15264BA
- 15243BB and 15215AE
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- 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
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- HighSiemens Dimension Vista Magnesium Reagent Cartridge Recall for Low Results
FDA (Devices) · 2015-12-02
- ModerateSiemens Recalls Dimension Vista Urinary Protein Reagent Cartridges
FDA (Devices) · 2013-10-23
- HighSiemens Dimension Vista Calcium Flex Reagent Cartridge Recalled for Low Results
FDA (Devices) · 2018-05-09
- HighSiemens Dimension Vista B2 Microglobulin Reagent Cartridge Recall
FDA (Devices) · 2016-03-09
- HighSiemens Recalls Dimension Vista B2-Microglobulin Reagent Cartridges
FDA (Devices) · 2015-09-02
- HighSiemens Magnesium Flex reagent cartridge recalled for imprecision and assay errors
FDA (Devices) · 2022-04-06