Diagnostic test shows measurement bias at critical threshold
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.
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: This is an FDA Class II recall addressing a measurement inaccuracy (positive bias) in a diagnostic test. No illnesses or injuries have been reported. The issue is treated as a precautionary recall to prevent potential misinterpretation of patient results.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur CA 19-9 test kits (lot numbers 55970535 and 55971535) used to measure CA 19-9 tumor-associated antigen levels in patient blood samples. These in vitro diagnostic tests are used with Atellica CI and Atellica IM analyzers for quantitative measurement of CA 19-9.
The recalled test kits produce artificially elevated (positive bias) measurements for some samples, particularly around the upper limit of normal of 35 U/mL. The bias is most pronounced in samples from the Asia Pacific region and is not consistent across all measurement ranges—the effect is less pronounced for samples with results above 110 U/mL.
The affected test kits have been distributed nationwide in the United States and worldwide. Healthcare facilities using these specific lot numbers should review their testing practices and contact Siemens Healthcare Diagnostics for guidance on managing affected kits and assessing potential impact on prior patient results.
The recalled product
- Product
- ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (3)
- UDI-DI: (01)00630414574257(10)55970535(17)20240914
- (01)00630414574257(10)55971535(17)20240914 Kit Lot: 55970535
- 55971535
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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 5 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
- ModerateSiemens ADVIA Centaur CA 19-9 Assay Recalled for Temperature Sensitivity
FDA (Devices) · 2012-12-19
- HighADVIA Centaur aTPO Assay kits recalled due to positive result bias
FDA (Devices) · 2024-10-09
- HighSiemens ADVIA Centaur Cortisol Diagnostic Kits Recalled for Negative Measurement Bias
FDA (Devices) · 2023-05-10
- ModerateSiemens ADVIA Centaur BR Assay Recalled for Quality Control Issues
FDA (Devices) · 2012-11-07
- ModerateSiemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues
FDA (Devices) · 2016-11-23
- ModerateSiemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias
FDA (Devices) · 2019-05-08