Immunotech A.S.: Estrone RIA, REF: DSL8700
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Immunotech A.S.
- Product
- Estrone RIA, REF: DSL8700
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
- Recall initiated
- 2025-12-15
- Code info
- UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
- Product quantity
- 160
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Prague 10
- Country
- Czech Republic
- Event id
- 98219
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