FDA recall, , Moderate risk
Immunotech Estrone RIA
Estrone RIA may rarely give falsely high patient results, which might cause temporary injury.
Summary by Recall Canary from the FDA notice
What happened
Immunotech A.S., based in Prague 10, Czech Republic, recalled Estrone RIA, REF: DSL8700, on December 15, 2025, because affected kit lots may rarely give falsely high patient results, which might cause temporary injury. The FDA added the recall to its Enforcement Report on February 13, 2026, and classified it that same day.
Distribution was worldwide, including nationwide in the U.S. state of North Carolina and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, and Italy.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Estrone RIA
- UDI-DI
- 15099590211615
- Reference number
- DSL8700
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the state of North Carolina and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
- Company
- Immunotech A.S.Prague 10, Czech Republic
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98219
- Recall number
- Z-1369-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
