Siemens Atellica CH Direct Bilirubin Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling Atellica CH Direct Bilirubin assays because they may show 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. The hazard involves potential inaccurate test results (positive bias) for a specific medication, which is a moderate risk of misdiagnosis but does not involve direct physical injury or death.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Direct Bilirubin_2 assay, an in vitro diagnostic used to measure direct bilirubin in human serum and plasma. The recall is due to the potential for the assay to exhibit a positive bias in patients receiving eltrombopag therapy.
The affected product is the Atellica CH Direct Bilirubin_2 assay (SMN: 11097532), used on ADVIA Chemistry systems for screening liver function disorders or diagnosing jaundice. The recall covers 577 units in the US and 2,617 units outside the US. Distribution was nationwide and included numerous foreign countries.
The specific lots affected are 190273, 190187, and 190120. Healthcare facilities using these assays should contact Siemens Healthcare Diagnostics for further instructions on handling the recalled product.
The recalled product
- Product
- Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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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