FDA DevicesClass II
Estrone RIA, REF: DSL8700
Published: February 25, 2026Recall ID: Z-1369-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Estrone RIA, REF: DSL8700
Additional Source Details
| Field | Value |
|---|---|
| City | Prague 10 |
| Event id | 98219 |
| Address 1 | Radiova 1 |
| Code info | UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27) |
| Postal code | N/A |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 160 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | Letter |
| Center classification date | 20260213 |
Overview
- Recalling FirmImmunotech A.S.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.