fda_recall · device_recall · high

DFI Co., Ltd. — Class II recall: Uric Acid in vitro diagnostic test REF: 31H0P

Event date
2026-05-13 00:00:00Z
Observed
2026-07-09 22:52:36Z
Source ID
Z-2086-2026
Payload hash
4c9df487f1fa582da43a03ed

Summary

The devices were distributed without required FDA premarket clearance or approval. Status: Ongoing.

Informational only. Not legal, financial, or medical advice.