Tosoh ST-AIA Prostate Assay Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA Prostate Assay kits because the drug Strensiq can cause inaccurate test 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 may cause temporary or medically reversible health consequences. The hazard is a diagnostic error (false results) rather than a direct physical injury or contamination, fitting the Moderate severity criteria for low-risk issues or labeling/interference errors.
Plain-English summary
Tosoh Bioscience Inc is recalling 1,083 units of the ST-AIA PACK PAP (Part Number: 025262) Prostate Assay. The recall covers all lot codes and includes products distributed in the United States, Canada, Mexico, and several other countries in the Americas.
The recall was initiated because the medication 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 being used.
Healthcare providers and laboratories should stop using the affected assay kits and contact Tosoh Bioscience for further instructions regarding the recall and potential replacement or refund.
The recalled product
- Product
- ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 1,083
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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