Siemens Dimension Vista Total Bilirubin Reagent Cartridge Recall
Siemens Healthcare Diagnostics is recalling Dimension Vista Total Bilirubin reagent cartridges because they may produce inaccurate results for patients taking eltrombopag.
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 a potential positive bias in test results for a specific medication, which is a moderate risk of diagnostic error rather than a direct physical injury or high-risk pathogen.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista Total Bilirubin Flex reagent cartridges. The recall is due to a potential positive bias in bilirubin assay results for patients receiving eltrombopag therapy. This in vitro diagnostic test is intended to quantitatively measure total bilirubin in human serum and plasma.
The affected product is distributed nationwide and in numerous foreign countries. The recall covers specific lot numbers and UDI numbers listed in the agency's records. The product is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders.
Healthcare providers should be aware that bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy. No specific consumer action is detailed in the source text beyond the identification of the affected lots.
The recalled product
- Product
- Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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