United StatesEstrone RIA kits (REF: DSL8700, UDI 15099590211615; lots 251013C exp. 2025-12-30 and 251110C exp. 2026-01-27) manufactured by Immunotech A.S. are being recalled. The kits may rarely produce falsely high patient results, which might cause temporary injury with remote probability. The recall covers 160 units distributed worldwide, including the U.S. (North Carolina) and the listed countries in Europe and elsewhere.
What's being recalled
Estrone RIA, REF: DSL8700
Recalling firm: Immunotech A.S., Prague 10, Czech Republic.
How to identify it
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)