Immunotech A.S. recalls Estrone RIA, REF: DSL8700

Recall date

December 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1369-2026

FDA classification

Class II

Brand / firm

Immunotech A.S.

Sold / distributed

Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Estrone RIA, REF: DSL8700