Class IIOngoingZ-2088-2026
DFI Co., Ltd. recalls One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
DFI Co., Ltd. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–7 of 7 recalls
Class IIOngoingZ-2087-2026
DFI Co., Ltd. recalls One Step K in vitro diagnostic test REF: 81A4
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Class IIOngoingZ-2086-2026
DFI Co., Ltd. recalls Uric Acid in vitro diagnostic test REF: 31H0P
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Class IIOngoingZ-2085-2026
DFI Co., Ltd. recalls QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Class IIOngoingZ-2084-2026
DFI Co., Ltd. recalls One Step pH in vitro diagnostic test REF: 31I4P
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Class IIOngoingZ-2083-2026
DFI Co., Ltd. recalls One Step UTI in vitro diagnostic test REF: 3374
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Class IIOngoingZ-2082-2026
DFI Co., Ltd. recalls One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026