Tosoh ST-AIA PACK HCG Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK HCG 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a diagnostic error due to drug interference, not a direct physical injury or life-threatening condition.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA PACK HCG (Part Number: 025261) Assay, Reproductive Hormone. The recall involves 12,614 units distributed worldwide, including the United States, Canada, Mexico, and various countries in South and Central America.
The recall is issued 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 stop using the affected product. Consumers should consult their healthcare provider regarding any recent test results that may have been affected by this interference.
The recalled product
- Product
- ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 12,614
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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