Siemens ADVIA Chemistry Direct Bilirubin Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Direct Bilirubin assays because they may show positive bias in 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 positive bias in test results for a specific patient population, which is a moderate risk of misdiagnosis or incorrect treatment without reported injuries or deaths.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Chemistry Direct Bilirubin_2 assay (SMN: 10316610 and 10341114) in 20 mL and 70 mL sizes. The recall is due to the potential for the assay to exhibit a positive bias when used on patients receiving eltrombopag therapy.
The affected products are in vitro diagnostic assays used for the quantitative determination of direct bilirubin in human serum and plasma on ADVIA Chemistry systems. These measurements are typically used to screen for liver function disorders or diagnose jaundice. The recall covers 1,901 units distributed in the United States and 37,349 units distributed internationally across numerous countries.
No specific instructions for consumers are provided in the source text, as the product is intended for in vitro diagnostic use in clinical settings. Healthcare facilities and laboratories should be aware of this potential bias when interpreting results for patients on eltrombopag.
The recalled product
- Product
- ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are
- 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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