Tosoh ST-AIA PACK IRI Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK IRI assays because Asfotase Alfa (Strensiq) interferes with the tests, 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 device) where the hazard is inaccurate diagnostic results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Tosoh Bioscience Inc is recalling 9,625 units of ST-AIA PACK IRI (Part Number: 025260), a diabetes assay. The recall is due to interference from the drug Asfotase Alfa (Strensiq), which can cause falsely increased or decreased immunoassay test results depending on the specific assay used.
The affected products were distributed worldwide, including the United States, Canada, Mexico, and several countries in Central and South America. All lot codes are included in this recall.
Healthcare providers and laboratories should stop using the affected assays and contact Tosoh Bioscience Inc for further instructions on handling the product and managing patient care.
The recalled product
- Product
- ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 9,625
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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