Tosoh ST-AIA PACK hsE2 Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA PACK hsE2 assays because Asfotase Alfa (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. The hazard involves potential diagnostic errors (falsely increased or decreased results) which poses a risk of harm to patients through misdiagnosis or inappropriate treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling 49 units of the ST-AIA PACK hsE2 (Part Number: 025225) Reproductive Hormone Assay. The recall is due to interference from Asfotase Alfa (Strensiq), which can cause falsely increased or decreased immunoassay test results.
The affected products were distributed worldwide, including the United States, Canada, Mexico, and various countries in Central and South America. The recall covers all lot codes for this specific product.
Healthcare providers and laboratories should stop using the affected assays and contact Tosoh Bioscience for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 49
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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