May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step P in vitro diagnostic test REF: 8194
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step K in vitro diagnostic test REF: 81A4
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls Uric Acid in vitro diagnostic test REF: 31H0P
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step pH in vitro diagnostic test REF: 31I4P
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step UTI in vitro diagnostic test REF: 3374
Hazard: The devices were distributed without required FDA premarket clearance or approval.
May 13, 2026Medical DevicesFDA
DFI Co., Ltd. recalls One Step 10A in vitro diagnostic test
Hazard: The devices were distributed without required FDA premarket clearance or approval.