Tosoh ST-AIA PACK T4 Thyroid Assay Recalled Due to Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK T4 thyroid assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for inaccurate test results due to interference, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA PACK T4 (Part Number: 025258) Thyroid Assay. The recall involves 14,690 units distributed worldwide, including the United States, Canada, Mexico, and various countries in South and Central America.
The recall is being conducted 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 facilities and laboratories that have purchased or are using these assays should stop using them and contact Tosoh Bioscience Inc for further instructions. Patients who have had thyroid tests performed using this specific assay may wish to consult their healthcare provider regarding the potential impact of the interference on their results.
The recalled product
- Product
- ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 14,690
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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