Estrone RIA, REF: DSL8700
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 15, 2025 |
| Reported | February 25, 2026 |
| Recalling firm | Immunotech A.S. |
| Country / region | Czech Republic Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy. |
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.
Affected products
- Estrone RIA, REF: DSL8700
Related recalls
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