# FDA recall Z-0804-2026

> **GET TESTED INTERNATIONAL AB** · Class II · device recall initiated 2025-11-03.

## Product

Allergy test Small

## Reason for recall

Distribution without premarket approval/clearance.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0804-2026
- **Recalling firm:** GET TESTED INTERNATIONAL AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-03
- **Report date:** 2025-12-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vastervik, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2026

## Citation

> AI Analytics. FDA recall Z-0804-2026. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0804-2026. Source: US FDA. Licensed CC0.

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