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DFI Co., Ltd. recalls One Step UTI in vitro diagnostic test REF: 3374
Recalled May 13, 2026 · FDA recall Z-2083-2026 · DFI
Hazard
The devices were distributed without required FDA premarket clearance or approval. · FDA Class II
Units
2423 units
Sold at
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Description
The devices were distributed without required FDA premarket clearance or approval.
Product
One Step UTI in vitro diagnostic test REF: 3374
Manufacturer(s)
DFI Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →