Tosoh ST-AIA DHEA-S Assay Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA DHEA-S assays because Asfotase Alfa (Strensiq) interferes with the test, 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. The hazard involves potential diagnostic errors due to drug interference, which fits the criteria for moderate severity as it poses a risk of incorrect medical decisions without direct physical injury or death reported.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA DHEA-S Assay, Part Number 025222. The recall involves 1,442 units distributed nationwide in the US and in several countries in the Americas, including Canada, Mexico, and various Central and South American nations.
The recall was initiated because Asfotase Alfa (Strensiq) interferes with the assay. 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 DHEA-S test results when using this specific Tosoh assay.
The recalled product
- Product
- ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 1,442
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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