FDAJune 12, 2025device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
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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