FDA Enforcement
Class II
Ongoing
Estrone RIA, REF: DSL8700
Recall: Z-1369-2026
·
Reported February 25, 2026
Enforcement
- Recall Number
- Z-1369-2026
- Event ID
- 98219
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Immunotech A.S.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 25, 2026
- Initiation Date
- December 15, 2025
- Classification Date
- February 13, 2026
- Address
- Radiova 1, Prague 10, N/A, Czech Republic
Description
Estrone RIA, REF: DSL8700
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.
Code Info
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
Distribution
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Quantity
160