Tosoh Thyroid Assay Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA PACK FT4 assays because Asfotase Alfa (Strensiq) interferes with the tests, 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 involves a risk-of-harm product (medical device) where inaccurate test results could lead to incorrect medical decisions, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling ST-AIA PACK FT4 assays (Part Number: 025268) due to interference from the drug Asfotase Alfa (Strensiq). The recall covers 43,275 units distributed worldwide, including the United States, Canada, Mexico, and several countries in Central and South America.
The recall is issued because Asfotase Alfa interferes with certain Tosoh assays, which can potentially cause falsely increased or falsely decreased immunoassay test results depending on the specific assay. This interference may lead to inaccurate thyroid test results for patients taking the medication.
Healthcare providers and laboratories should stop using the affected ST-AIA PACK FT4 assays and contact Tosoh Bioscience for further instructions. Patients taking Asfotase Alfa should consult their healthcare provider regarding the potential impact on their thyroid test results.
The recalled product
- Product
- ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 43,275
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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