Siemens Atellica CH Total Bilirubin Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling Atellica CH Total Bilirubin assays because they may show inaccurate 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, and the hazard is a positive bias (inaccurate high results) rather than a direct physical injury or contamination, fitting the Moderate criteria for low-risk issues or voluntary precautionary recalls.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Total Bilirubin_2 assay (SMN: 11097531). This in vitro diagnostic product is used to measure total bilirubin in human serum and plasma for adults and neonates. The recall involves 2,323 units in the US and 8,193 units outside the US, distributed to numerous countries worldwide.
The recall is issued because the bilirubin assays may exhibit a positive bias when used on patients receiving eltrombopag therapy. This means the test results may be falsely elevated for these specific patients. The affected lots include 190028, 190063, 190112, 190152, 190205, 190235, and 190265.
Healthcare facilities and laboratories should stop using the affected lots of the Atellica CH Total Bilirubin_2 assay. Siemens Healthcare Diagnostics is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin)…
- 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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