Tosoh ST-AIA PACK IGE II Recalled Due to Strensiq Interference
Tosoh Bioscience is recalling ST-AIA PACK IGE II allergy assays because 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 involves a medical device where the hazard is inaccurate test results (falsely increased or decreased) which could lead to incorrect medical decisions. This fits the 'High' criteria for risk-of-harm products where injury has not yet been reported, as the source does not mention any reported illnesses or injuries.
Plain-English summary
Tosoh Bioscience Inc is recalling 2,867 units of the ST-AIA PACK IGE II Assay, Allergy (Part Number: 025295). The recall covers all lot codes and includes products distributed nationwide in the US and in Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Honduras, Ecuador, Cayman Islands, Panama, and Costa Rica.
The recall is being issued 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 be aware that patients taking Asfotase Alfa may have inaccurate allergy test results when using this specific assay. No specific consumer action is detailed in the source text beyond the identification of the affected product and the nature of the interference.
The recalled product
- Product
- ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 2,867
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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