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

Recalled February 25, 2026 · FDA recall Z-1369-2026 · Immunotech A.S

Hazard
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. · FDA Class II
Units
160
Sold at
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.

Description

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.

Product
Estrone RIA, REF: DSL8700
Manufacturer(s)
Immunotech A.S.
Made in
Czech Republic

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

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