Tosoh Estradiol Assay Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA PACK Estradiol 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 involves a risk-of-harm product (medical diagnostic device) where inaccurate results could lead to improper medical 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 Estradiol Assay, Part Number 025274. The recall affects 16,080 units distributed worldwide, including the United States, Canada, Mexico, and several other countries in the Americas.
The recall was initiated because Asfotase Alfa (Strensiq) interferes with the assay. This interference can cause falsely increased or falsely decreased immunoassay test results. The source text does not specify which patients or specific lot codes are affected, noting only that all lot codes are involved.
Healthcare providers and laboratories should discontinue use of the affected assays to prevent inaccurate diagnostic results. Consumers should consult their healthcare providers regarding any recent test results that may have been affected by this interference.
The recalled product
- Product
- ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 16,080
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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