# FDA recall Z-2336-2025

> **Immunotech A.S.** · Class II · device recall initiated 2025-06-12.

## Product

Estrone RIA Catalog Number DSL8700  UDI Code: 15099590211615    Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.

## Reason for recall

Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of NC and the countries of Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, and  Netherlands.

## Key facts

- **Recall number:** Z-2336-2025
- **Recalling firm:** Immunotech A.S.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-12
- **Report date:** 2025-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Prague 10, N/A, Czech Republic

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2336-2025

## Citation

> AI Analytics. FDA recall Z-2336-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2336-2025. Source: US FDA. Licensed CC0.

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