Tosoh C-Peptide Assay Recalled Due to Strensiq Interference
Tosoh Bioscience Inc is recalling ST-AIA PACK C-Peptide 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 is classified as FDA Class II and involves a risk of harm (inaccurate test results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Tosoh Bioscience Inc is recalling the ST-AIA PACK C-Peptide assay (Part Number: 025284) due to interference from the drug Asfotase Alfa (Strensiq). The recall affects 1,358 units distributed worldwide, including the United States, Canada, Mexico, and several other countries in the Americas.
The interference from Asfotase Alfa can cause falsely increased or falsely decreased immunoassay test results. This issue may lead to inaccurate clinical data for patients taking the medication. The recall covers all lot codes for this specific product.
Healthcare providers and laboratories should stop using the affected assays and contact Tosoh Bioscience Inc for further instructions. Patients should consult their healthcare providers regarding any recent test results that may be affected by this interference.
The recalled product
- Product
- ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 1,358
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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