Class II

Medical Device Recall: Estrone RIA, REF: DSL8700

Immunotech A.S. · December 15, 2025

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.

Distribution

Worldwide - US Nationwide distribution in the state of NC and the countries of Germany, Argentina, Netherlands, Hungary, Austria, Belgium, France, Italy.

States Affected

NATIONWIDE

Quantity Affected

160

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1369-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.