Tosoh ST-AIA PACK Testosterone Assay Recalled Due to Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK Testosterone assays because Asfotase Alfa 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 is classified as FDA Class II, and the hazard involves potential diagnostic errors (falsely increased or decreased results) which poses a risk of harm to patients through incorrect medical decisions, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA PACK Testosterone Assay, Part Number 025204. The recall involves 10,913 units distributed worldwide, including the United States, Canada, Mexico, and several countries in South and Central America.
The recall is being 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 and contact Tosoh Bioscience Inc for further instructions regarding the recall and potential replacement or refund.
The recalled product
- Product
- ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 10,913
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.
See all 35 products in this recall →Related recalls
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