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Estrone RIA, REF: DSL8700

FDA Recall #Z-1369-2026 — Class II — December 15, 2025

Recall #Z-1369-2026 Date: December 15, 2025 Classification: Class II Status: Ongoing

Product Description

Estrone RIA, REF: DSL8700

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.

Recalling Firm

Immunotech A.S. — Prague 10

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

160

Distribution

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

Code Information

UDI: 15099590211615. Lot(Expiration): 251013C(2025-12-30), 251110C(2026-01-27)

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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