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, and the hazard involves inaccurate test results (positive bias) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics is recalling specific lots of the T3F, Free T3 Assay kits (REF/Catalog Numbers L2KF32 and L2KF36) used with IMMULITE 2000 and IMMULITE 200 XPi analyzers. The recall affects 4,695 kits distributed worldwide, including the United States and numerous international markets. The affected lot numbers are 737, 738, 739, 740, 741, 742, and 743.
The recall was initiated after the manufacturer confirmed customer complaints regarding an increase in euthyroid patients (those with normal thyroid function) showing values above the recommended normal range. Additionally, a positive bias was observed in quality control results, although these values may remain within established ranges. This issue could lead to inaccurate clinical assessments of thyroid status.
Healthcare facilities and laboratories should stop using the affected kits and contact Siemens Healthcare Diagnostics for instructions on returning the product. Consumers should consult their healthcare providers if they have recently received Free T3 test results using these specific kits to discuss the potential impact on their diagnosis.
The recalled product
- Product
- T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare…
- Manufacturer
- Siemens Healthcare Diagnostics
- Affected units
- 4,695
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 (7)
- Lot Numbers 737
- 738
- 739
- 740
- 741
- 742
- 743
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.
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