DFI Co., Ltd. recalls Uric Acid in vitro diagnostic test REF: 31H0P
- Recall date
- April 2, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2086-2026
- FDA classification
- Class II
- Brand / firm
- DFI Co., Ltd.
- Sold / distributed
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Why it was recalled
The devices were distributed without required FDA premarket clearance or approval.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Uric Acid in vitro diagnostic test REF: 31H0P
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