Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.
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, but the source text describes a standardization bias without reporting any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 10,673 units of the Siemens ADVIA Centaur aTG (100 test kit) (SMN: 10492398). The recall affects specific lots with expiration dates ranging from December 2018 to June 2019. The products were distributed nationwide and in numerous foreign countries.
The recall was initiated because the test kits exhibit positive bias in anti-thyroglobulin results when compared to the standardization to the World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use. This discrepancy may affect the accuracy of test results.
Healthcare facilities and distributors should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions. Consumers should not use these products for diagnostic purposes.
The recalled product
- Product
- Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 10,673
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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 4 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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighADVIA Centaur aTPO Assay kits recalled due to positive result bias
FDA (Devices) · 2024-10-09
- HighSiemens ADVIA Centaur Progesterone Kit Recalled for High Bias in Results
FDA (Devices) · 2015-03-11
- ModerateSiemens ADVIA Centaur Progesterone Kit Recalled for High Result Bias
FDA (Devices) · 2015-03-11
- ModerateSiemens ADVIA Centaur Progesterone Kit Recall for High Bias in Results
FDA (Devices) · 2015-03-11
- ModerateSiemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias
FDA (Devices) · 2017-03-08
- ModerateSiemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias
FDA (Devices) · 2013-04-24