Siemens Atellica IM Erythropoietin assay recalled for calibration bias error
Siemens has recalled the Atellica IM Erythropoietin assay due to a 35% negative bias compared to WHO standards. The assay does not achieve claimed reference intervals and could report inaccurate test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The 35% measurement bias creates a risk-of-harm (inaccurate diagnostic results in a clinical assay), but no actual injuries have been documented. Per the rubric, this qualifies as High (Score 3).
Plain-English summary
Siemens Healthcare Diagnostics is recalling the Atellica IM Erythropoietin (EPO) Assay (100 Test). The assay is used in clinical laboratories to measure erythropoietin levels, a hormone important in diagnosing and monitoring anemia and other blood disorders.
Siemens has identified a consistent negative bias of 35% in results from affected lots when compared to the World Health Organization International Standard. The reference interval specified in the product instructions for use is not achieved with these lots, meaning the assay reports erythropoietin values that are systematically lower than the true values.
Approximately 1,057 units have been distributed worldwide, including 46 units in the United States across 12 states (AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH, TX) and 1,011 units internationally. The affected kit lots are 53982039 and 55439041.
Laboratories using affected lots should contact Siemens for guidance on corrective actions. Clinical staff should be aware of the measurement inaccuracy when interpreting results from these assays and consider whether previously reported results from affected lots require review.
The recalled product
- Product
- Atellica IM Erythropoietin (EPO) Assay (100 Test)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- measurement-bias
- assay-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Siemens Material Number: 10733006
- UDI/DI: 00630414245775
- Kit Lots: 53982039
- 55439041.
Distribution
Distributed nationwide across the United States.
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