Prague 10, N/A, Czech Republic
Immunotech A.S. recalls
2 recalls recorded since 2018, most recently on 15 December 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 December 2025
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1369-2026
- Estrone RIA, REF: DSL8700
Ongoing Class II Medical devices
- Recall started
- 12 June 2025
- Reason
- 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.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2336-2025
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.