ST-AIA PACK T4 — Class II medical device recall Z-2079-2018
Terminated recall by Tosoh Bioscience Inc, reported 2018-06-13, distributed nationwide. Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or fa
| Recall number | Z-2079-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience Inc, Grove City, OH, United States |
| Recall initiated | 2018-03-05 |
| Classified | 2018-06-05 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CA, CL, CR, HN, MX, NI, PA, PE, UY |
| Quantity | 14,690 |
| Reason classes | potency |
| Model numbers | 025258 |
Product
ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
Reason for recall
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2079-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.