Tosoh ST-AIA SHBG Assay Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA SHBG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 is a significant quality issue but does not involve direct physical injury or a high-risk pathogen, fitting the Moderate criteria for labeling/quality issues.
Plain-English summary
Tosoh Bioscience Inc is recalling 539 units of the ST-AIA PACK SHBG (Part Number: 025238) Reproductive Hormone Assay. The recall affects all lot codes and covers units distributed in the United States, Canada, Mexico, and various countries in Central and South 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 ST-AIA PACK SHBG assays. Users should contact Tosoh Bioscience Inc for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 539
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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