Abbott Recalls Free T3 Reagent Kits Due to Carryover Issues
Abbott Ireland Diagnostics Division is recalling ARCHITECT Free T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.
What this means for you
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. The hazard involves inaccurate test results (depressed values) due to reagent carryover, which is a significant quality issue but does not involve direct physical injury or reported illnesses, fitting the Moderate category for low-risk contamination or labeling/quality errors without reported harm.
Plain-English summary
Abbott Ireland Diagnostics Division is recalling 191,410 units of ARCHITECT Free T3 Reagent Kits. These kits are used on ARCHITECT i1000SR or i2000/i2000SR platforms to measure free triiodothyronine (Free T3) in human serum and plasma. The recall covers specific kit configurations and all associated lot codes.
The recall was initiated because samples tested using the ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results. This issue is attributed to reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms. The product was distributed nationwide in the United States and internationally to numerous countries.
Healthcare providers and laboratories should stop using the affected reagent kits and contact Abbott Ireland Diagnostics Division for instructions on how to return the product. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
- Manufacturer
- Abbott Ireland Diagnostics Division
- Affected units
- 191,410
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 (6)
- List number (Kit Configuration): 7K63-20 (4 x 100 tests/kit)
- 7K63 25 (1 x 100 tests/kit)
- 7K63 27 (1 x 100 tests/kit)
- 7K63 30 (4 x 500 tests/kit)
- 7K63 35 (1 x 500 tests/kit)
- 7K63 32 (4 x 500 tests/kit)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Abbott Ireland Diagnostics Division 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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