Siemens ADVIA Chemistry Total Bilirubin Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Total Bilirubin assays because they may show falsely high results for patients taking eltrombopag.
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. The hazard is a potential diagnostic error (positive bias) rather than a direct physical injury or contamination, fitting the criteria for moderate severity involving low-risk issues or precautionary measures.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Chemistry Total Bilirubin_2 assay (SMN: 10341115 and 10341113). The recall affects 5,666 units in the United States and 52,202 units distributed internationally.
The recall was initiated because the bilirubin assays may exhibit a positive bias when used on patients receiving eltrombopag therapy. This means the tests could produce falsely elevated total bilirubin results for these specific patients. The product is used for in vitro diagnostic purposes to measure total bilirubin in human serum and plasma.
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on how to return or dispose of the product. The recall covers specific lot numbers with expiration dates ranging from March 2020 to August 2021.
The recalled product
- Product
- ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry system
- 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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