Siemens Total Bilirubin Reagent Cartridge Recall for Eltrombopag Interference
Siemens Healthcare is recalling Dimension Total Bilirubin Flex reagent cartridges because the assay may show falsely high 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. The hazard is a potential for inaccurate test results (positive bias) in a specific patient population (those on eltrombopag), which fits the criteria for moderate severity involving low-risk contamination or minor labeling/functional errors without reported serious injuries.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Total Bilirubin Flex reagent cartridges (SMN: 10444957). The recall involves 1,639 units in the United States and 747 units in foreign markets. The product is an in vitro diagnostic test used to measure total bilirubin in human serum and plasma, which is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders.
The recall is being conducted because bilirubin assays using these cartridges may exhibit a positive bias in patients who are on eltrombopag therapy. This means the test results may be falsely elevated for these specific patients. The affected lots were distributed nationwide in the US and to numerous foreign countries including those in Europe, Asia, Africa, and the Americas.
Healthcare facilities and laboratories should stop using the affected lots of the Dimension Total Bilirubin Flex reagent cartridge. Siemens Healthcare Diagnostics, Inc. is the recalling firm. Users should contact the manufacturer for further instructions on how to manage the recall and replace the affected units.
The recalled product
- Product
- Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total…
- 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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