Immunotech A.S.: Device Recall
Recall #Z-2336-2025 · 06/12/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2336-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Immunotech A.S.
- Status
- Ongoing
- Date Initiated
- 06/12/2025
- Location
- Prague 10, N/A, Czech Republic
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 279 units
Reason for Recall
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.
Product Description
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.
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.