Siemens Free T3 Assay Kits Recalled for Positive Bias in Results
Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.
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, which typically corresponds to a moderate severity score. The hazard involves a positive bias in test results that could lead to misdiagnosis, but the source does not report any hospitalizations, serious injuries, or deaths.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 2,201 units of the T3F, Free T3 Assay (REF/Catalog Number LKF31, SMN 10381626) for use with IMMULITE/IMMULITE 1000 analyzers. The affected lots are 353 and 354. These kits are used for the quantitative measurement of Free T3 in serum to aid in the clinical assessment of thyroid status.
The recall was initiated after the company confirmed customer complaints regarding an increase in euthyroid patients (those with normal thyroid function) demonstrating values above the recommended normal range. A positive bias in quality control results was also observed, although values may remain within established ranges.
The affected kits were distributed worldwide, including nationwide in the United States and in numerous other countries. The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of the kits.
The recalled product
- Product
- T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products…
- Manufacturer
- Siemens Healthcare Diagnostics
- Affected units
- 2,201
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 (2)
- Lot Numbers 353
- 354
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics 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
See all →- ModerateSiemens BC Thrombin Reagent Kit Recall for Unexpected Prolonged Results
FDA (Devices) · 2018-03-07
- ModerateSiemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias
FDA (Devices) · 2014-10-29
- ModerateSiemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error
FDA (Devices) · 2014-10-08
- ModerateSiemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading
FDA (Devices) · 2014-09-24
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
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
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighSiemens IMMULITE 2000 Anti-TG Ab Test Kits Recalled for Falsely Elevated Results
FDA (Devices) · 2024-05-29
- HighSiemens IMMULITE Thyroid Test Kit Recalled for Falsely Low Results
FDA (Devices) · 2022-10-05
- HighThyroid Autoantibody Test System Recalled for Falsely Elevated Results
FDA (Devices) · 2024-05-29
- HighSiemens IMMULITE TBG Test Kits Recalled for Inaccurate Results
FDA (Devices) · 2015-05-27
- ModerateSiemens IMMULITE Total IgE Assay Recalled for Positive Bias
FDA (Devices) · 2014-05-07
- ModerateSiemens Recalls Intact PTH Assay Kits Due to Negative Bias
FDA (Devices) · 2017-01-18