Immunotech A.S. — 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 meas
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 12, 2025
Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and Netherlands.
What's affected?
- 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.
- Brand
- Immunotech A.S.
- Lot code
- 241014D
Additional details
Catalog Number DSL8700 UDI Code: 15099590211615 Serial/Lot Numbers: 241014D 241111C 241209C 241209D 250106C 250106D 250203C
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 279 units.
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