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
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, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling 66 units of the ST-AIA PACK HCG assay (Part Number: 025256). The recall covers all lot codes and includes products distributed in the United States, Canada, Mexico, and various countries in Central and South America.
The recall was initiated 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 ST-AIA PACK HCG assays and contact Tosoh Bioscience Inc for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 66
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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