Tosoh ST-AIA PACK FT3 Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.
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 potential test interference leading to inaccurate results, but the source text does not report any hospitalizations, serious injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA PACK FT3 Assay, Thyroid (Part Number: 025286). The recall involves 12,055 units distributed nationwide in the US and in Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Honduras, Equador, Caymen Islands, Panama, and Costa Rica. All lot codes are affected.
The recall was initiated because Asfotase Alfa (Strensiq) interferes with certain Tosoh assays. This interference can potentially cause falsely increased or falsely decreased immunoassay test results, depending on the specific assay used.
Healthcare providers and laboratories should be aware that patients taking Asfotase Alfa may have inaccurate FT3 test results when using this specific Tosoh assay. No specific consumer action is detailed in the source text beyond the identification of the affected product and the nature of the interference.
The recalled product
- Product
- ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 12,055
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 (1)
- All Lot Codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 35 recalled by Tosoh Bioscience 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.
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