Tosoh ST-AIA PACK AFP Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK AFP 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 3/5 (High).
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 medical device where the hazard is the potential for inaccurate diagnostic results due to drug interference. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tosoh Bioscience Inc is recalling 3,254 units of ST-AIA PACK AFP (Part Number: 025252), a tumor marker 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 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 AFP assays. Users should contact Tosoh Bioscience Inc for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 3,254
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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