Tosoh FSH Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc. is recalling ST-AIA PACK FSH assays because the drug Asfotase Alfa (Strensiq) can cause inaccurate test 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 for inaccurate diagnostic results (falsely increased or decreased) due to drug interference, which poses a risk of harm 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 the ST-AIA PACK FSH (Part Number: 025265), a reproductive hormone assay. The recall involves 9,033 units distributed nationwide in the United States and in several countries in the Americas, including Canada, Mexico, and various Central and South American nations.
The recall is being conducted because the drug 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 FSH assays. Patients who have received test results using these assays should consult their healthcare provider to discuss the potential impact of this interference on their results.
The recalled product
- Product
- ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 9,033
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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