FDAFDA · Food and drugs·Recall number Z-1369-2026
Estrone RIA, REF: DSL8700
Published February 25, 2026 · Recall initiated: December 15, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Immunotech A.S.
- Distributor
- Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.
- Lot
- UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Czech Republic
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