FDAHealthDecember 15, 2025
Immunotech A.S. — Estrone RIA, REF: DSL8700
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 15, 2025
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
What's affected?
- Product
- Estrone RIA, REF: DSL8700
- Brand
- Immunotech A.S.
- Lot code
- (Expiration):
Additional details
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 160.
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