fda_recall · device_recall · high
DFI Co., Ltd. — Class II recall: One Step UTI in vitro diagnostic test REF: 3374
- Event date
- 2026-05-13 00:00:00Z
- Observed
- 2026-07-09 22:52:40Z
- Source ID
- Z-2083-2026
- Payload hash
- 7a523a183e86702a71242fd3…
Summary
The devices were distributed without required FDA premarket clearance or approval. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.