Z-1369-2026 Class II Ongoing
FDA device recall Z-1369-2026 was initiated by Immunotech A.S. on December 15, 2025 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 160.
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2026
- Initiation Date
- December 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160
Product Description
Estrone RIA, REF: DSL8700
Reason for Recall
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 Pattern
Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
Code Information
UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)