fda_recall · device_recall · high
DFI Co., Ltd. — Class II recall: One Step 10A in vitro diagnostic test
- Event date
- 2026-05-13 00:00:00Z
- Observed
- 2026-07-09 22:52:39Z
- Source ID
- Z-2082-2026
- Payload hash
- 80c4fd621e41a0784d342e8a…
Summary
The devices were distributed without required FDA premarket clearance or approval. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.