Immunotech A.S. recalls Estrone RIA
- Recalling company
- Immunotech A.S.
- Product
- Estrone RIA, REF: DSL8700
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 15, 2025
- Reported
- Feb 25, 2026
- Distribution
- Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
- Status
- Ongoing
- Quantity
- 160
- Lot / codes
- UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
- Company location
- Prague 10
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1369-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1369-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.