dfi co., ltd.
7 recalls on record
D
DFI Co., Ltd. — One Step pH in vitro diagnostic test REF: 31I4P
The devices were distributed without required FDA premarket clearance or approval.
FDAHealth
D
DFI Co., Ltd. — One Step K in vitro diagnostic test REF: 81A4
The devices were distributed without required FDA premarket clearance or approval.
FDAHealth
D
DFI Co., Ltd. — Uric Acid in vitro diagnostic test REF: 31H0P
The devices were distributed without required FDA premarket clearance or approval.
FDAHealth
D
DFI Co., Ltd. — QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
The devices were distributed without required FDA premarket clearance or approval.
FDAHealth
D
DFI Co., Ltd. — One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
FDAHealth
D
DFI Co., Ltd. — One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
FDAHealth
D
DFI Co., Ltd. — One Step UTI in vitro diagnostic test REF: 3374
The devices were distributed without required FDA premarket clearance or approval.
FDAHealth