FDA (Devices) recall action 98739
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
The devices were distributed without required FDA premarket clearance or approval.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (761 units) because they were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.
The One Step P in vitro diagnostic test (REF 8194) was distributed without required FDA premarket clearance or approval. The manufacturer DFI Co., Ltd. is recalling the device.
DFI Co., Ltd. is recalling QUCARE Total Cholesterol in vitro diagnostic test devices because they were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.
DFI Co., Ltd. is recalling its Uric Acid in vitro diagnostic test (REF: 31H0P) because the devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance or approval.