One Step K in vitro diagnostic test REF: 81A4
Class II- Recalling firm
- DFI Co., Ltd.
- Reason for recall
- The devices were distributed without required FDA premarket clearance or approval.
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- Status
- Ongoing
- Recall number
- Z-2087-2026
- Recall initiated
- April 2, 2026