[pending] Estrone RIA, REF: DSL8700
Pending LLM rewrite. Source: FDA_DEVICE Z-1369-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- Estrone RIA, REF: DSL8700
- Manufacturer
- Immunotech A.S.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30)
- 251110C(2026-01-27)
Distribution
Distributed nationwide across the United States.
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