Siemens Recalls ADVIA Centaur Insulin Assay Kits Due to Accuracy Issues
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Insulin ReadyPacks because the assay results are approximately 40% higher than the WHO standard. The company states the overall risk to health is negligible.
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 source explicitly states that the overall risk to health is negligible and that the manufacturer does not recommend reviewing previous results, which aligns with the rubric for voluntary precautionary recalls or low-risk issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the ADVIA Centaur Systems Insulin ReadyPack (Test Code: IRI; Catalog Number: 02230141). The affected products are used for in vitro diagnostic testing to quantitatively determine insulin levels in serum. The recall includes kit lots ending in 169, 170, 173, and 174.
The recall was initiated because current lots of the assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met according to the assay Instructions for Use.
The products were distributed in the United States and numerous countries outside the US. Siemens states that the overall risk to health is negligible and is not recommending a review of previously generated results.
The recalled product
- Product
- ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
- 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 (4)
- Kit Lots Ending: 169
- 170
- 173
- 174
Distribution
Distribution scope not specified by the agency.
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 · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateSiemens ADVIA Centaur CA 125II Assay Recalled for Over-Recovery
FDA (Devices) · 2018-05-02
- ModerateSiemens ADVIA Centaur iPTH Assay Recalled for Variability
FDA (Devices) · 2013-06-12
- ModerateSiemens ADVIA Centaur BR Assay Recalled for Quality Control Issues
FDA (Devices) · 2012-11-07
- SevereSiemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance
FDA (Devices) · 2014-07-09
- HighSiemens ADVIA Centaur Progesterone Kit Recalled for High Bias in Results
FDA (Devices) · 2015-03-11
- ModerateSiemens ADVIA Centaur Immunoassay Systems Recalled for Sample Rack Loading Issues
FDA (Devices) · 2014-09-24