FDAHealthApril 2, 2026
DFI Co., Ltd. — One Step K in vitro diagnostic test REF: 81A4
⚠️ The devices were distributed without required FDA premarket clearance or approval.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 2, 2026
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
What's affected?
- Product
- One Step K in vitro diagnostic test REF: 81A4
- Brand
- DFI Co., Ltd.
- Lot code
- 241023
Additional details
UDI:08806141302650/ Lot: 241023, 250625, 250905
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 761 units.
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