fda_recall · device_recall · high
DFI Co., Ltd. — Class II recall: One Step K in vitro diagnostic test REF: 81A4
- Event date
- 2026-05-13 00:00:00Z
- Observed
- 2026-07-09 22:52:34Z
- Source ID
- Z-2087-2026
- Payload hash
- 1d904a22c95f7a0b5ead4510…
Summary
The devices were distributed without required FDA premarket clearance or approval. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.