Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone… — Class II medical device recall Z-2336-2025
Ongoing recall by Immunotech A.S., reported 2025-08-27, distributed nationwide. Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote
| Recall number | Z-2336-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immunotech A.S., Prague 10, N/A, Czech Republic |
| Recall initiated | 2025-06-12 |
| Classified | 2025-08-18 |
| Reported by FDA | 2025-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, CA, DE, FR, GR, HU, IT, NL |
| Quantity | 279 units |
| UPC / GTIN / UDI-DI | 15099590211615 |
| Lot numbers | 241014D, 241111C, 241209C, 241209D, 250106C, 250106D, 250203C |
| Model numbers | DSL8700 |
Product
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
Reason for recall
Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.
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-2336-2025. 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.