Estrone RIA — Class II medical device recall Z-1369-2026
Ongoing recall by Immunotech A.S., reported 2026-02-25, distributed nationwide. The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary inj
| Recall number | Z-1369-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immunotech A.S., Prague 10, Czech Republic |
| Recall initiated | 2025-12-15 |
| Classified | 2026-02-13 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, DE, FR, HU, IT, NL |
| Quantity | 160 |
| UPC / GTIN / UDI-DI | 15099590211615 |
| Model numbers | DSL8700 |
Product
Estrone RIA, REF: DSL8700
Reason for recall
The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary 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-1369-2026. 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.