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.
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 3/5 (High).
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.
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
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · measurement bias
See all →- HighEmano Flow Uroflowmetry App Recalled Over Biased Flow Estimates
FDA (Devices) · 2026-07-29
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighCapillary tubes recalled over a positive bias in potassium results
FDA (Devices) · 2026-02-25
- HighVITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results
FDA (Devices) · 2024-12-04
- Highepoc BGEM BUN Test Cards recalled for sodium measurement bias
FDA (Devices) · 2024-11-13
Similar recalls
- HighAtellica IM aTPO Assay Diagnostic Test Recalled for Measurement Bias
FDA (Devices) · 2024-10-09
- ModerateSiemens Atellica IM aTG Test Kits Recalled for Positive Bias
FDA (Devices) · 2019-05-08
- HighSiemens Atellica IM Folate 140 test kit recalled for measurement bias
FDA (Devices) · 2023-03-01
- HighSiemens Atellica IM Folate 700 test kit recalled for measurement bias
FDA (Devices) · 2023-03-01
- HighAtellica IM Folate test kit recalled for measurement bias issues
FDA (Devices) · 2023-03-01
- HighSiemens Atellica IM CA 19-9 Assay Recalled for Positive Bias
FDA (Devices) · 2024-09-18