Device product
Estrone RIA, REF: DSL8700
Z-1369-2026
Product summary
- Firm
- Immunotech A.S.
- Event
- Event 98219
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 160
- Official record key
device-enforcement:Z-1369-2026
Official wording
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 information: UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
Distribution pattern: Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Derived failure modes
-
Unknown
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.