Tosoh Thyroid Assay Recalled Due to Drug Interference
Tosoh Bioscience is recalling ST-AIA PACK TT3 thyroid assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic errors (falsely increased or decreased results) which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling 10,424 units of the ST-AIA PACK TT3 (Part Number: 025282) thyroid assay. The recall covers all lot codes and includes products distributed in the United States, Canada, Mexico, and several other countries in the Americas.
The recall was initiated because the drug 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 stop using the affected ST-AIA PACK TT3 assays and contact Tosoh Bioscience for further instructions regarding the recall and potential replacement or refund.
The recalled product
- Product
- ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 10,424
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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