Tosoh ST-AIA C-Peptide II Assay Recalled Due to Drug Interference
Tosoh Bioscience is recalling ST-AIA PACK C-Peptide II assays because the drug Asfotase Alfa 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 is classified as FDA Class II, and the hazard involves a risk of harm (inaccurate diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Tosoh Bioscience Inc is recalling 2,982 units of the ST-AIA PACK C-Peptide II assay (Part Number: 025283). 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 the drug 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 receive inaccurate C-Peptide test results when using this specific Tosoh assay. Users should consult with Tosoh Bioscience for guidance on alternative testing methods or handling of affected samples.
The recalled product
- Product
- ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 2,982
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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