FDADecember 15, 2025device
Estrone RIA, REF: DSL8700
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
immunotech a simmunotech
UPCs
15099590211615
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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