# FDA recall Z-1369-2026

> **Immunotech A.S.** · Class II · device recall initiated 2025-12-15.

## Product

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.

## Distribution

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

## Key facts

- **Recall number:** Z-1369-2026
- **Recalling firm:** Immunotech A.S.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-15
- **Report date:** 2026-02-25

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2026

## Citation

> AI Analytics. FDA recall Z-1369-2026. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1369-2026. Source: US FDA. Licensed CC0.

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