Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK BMG tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, 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 is classified as FDA Class II, and the hazard involves potential diagnostic errors (falsely increased or decreased results) which poses a risk of harm to patients, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Tosoh Bioscience Inc is recalling 3,406 units of the ST-AIA PACK BMG (Part Number: 025259) Assay, Tumor Marker. The recall affects all lot codes and covers worldwide distribution, including 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 assays and contact Tosoh Bioscience Inc for further instructions. Patients who have received test results using these assays should consult their healthcare provider to discuss the potential impact of the interference on their results.
The recalled product
- Product
- ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 3,406
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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