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DFI Co., Ltd. recalls One Step 10A in vitro diagnostic test
Recalled May 13, 2026 · FDA recall Z-2082-2026 · DFI
Hazard
The devices were distributed without required FDA premarket clearance or approval. · FDA Class II
Units
6533 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 10A in vitro diagnostic test
Manufacturer(s)
DFI Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →