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DFI Co., Ltd. recalls One Step K in vitro diagnostic test REF: 81A4
Recalled May 13, 2026 · FDA recall Z-2087-2026 · DFI
Hazard
The devices were distributed without required FDA premarket clearance or approval. · FDA Class II
Units
761 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 K in vitro diagnostic test REF: 81A4
Manufacturer(s)
DFI Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →