# FDA recall Z-2086-2026

> **DFI Co., Ltd.** · Class II · device recall initiated 2026-04-02.

## Product

Uric Acid in vitro diagnostic test    REF: 31H0P

## Reason for recall

The devices were distributed without required FDA premarket clearance or approval.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.

## Key facts

- **Recall number:** Z-2086-2026
- **Recalling firm:** DFI Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-02
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gimhae, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2086-2026

## Citation

> AI Analytics. FDA recall Z-2086-2026. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-2086-2026. Source: US FDA. Licensed CC0.

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