Reported Aug 27, 2025 · Ongoing
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device…
Immunotech A.S.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Immunotech A.S. · Radiova 1 · Prague 10, N/A · N/A
Is this the product you have?
- Estrone
- RIA Catalog Number DSL8700 UDI Code15099590211615 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
- Lot codes and dates
- Catalog Number DSL8700 UDI Code15099590211615
- Serial/Lot Numbers241014D 241111C 241209C 241209D 250106C 250106D 250203C
- Amount recalled
- 279 units
Where it was sold
- Nationwide
- NC
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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