Every recall we track for DFI Co., Ltd. — 7 in all — plus the complaints and injury reports the public filed about them.
DFI recalls One Step UTI diagnostic test (REF: 3374) due to lack of FDA premarket approval. Affected units sold with UDI 08806141303480 and lots 241023, 2:50625, 250905.
DFI recalls One Step 10A diagnostic tests distributed without FDA premarket approval. Affected lots: 241023, 250305, 250415, 250527, 250625, 250905. No remedy specified in official notice.
DFI recalls One Step pH test kits (REF: 31I4P) sold without FDA premarket approval. Consumers should check lot numbers for affected units.
DFI recalls One Step P in vitro diagnostic test REF: 819:1023, 250527, 250905 due to lack of FDA premarket approval. Consumers should check serial numbers for affected units.
QUCARE Total Cholesterol in vitro diagnostic tests without FDA premarket clearance are being recalled. Consumers should check product labels for lot numbers BS032501 to BS082501.
DFI Co., Ltd. recalls Uric Acid in vitro diagnostic test REF: 31H0P due to distribution without required FDA premarket clearance. Affected units include specific lot numbers.
DFI recalls One Step K diagnostic test (REF 81A4) due to lack of FDA premarket approval. Affected units sold from 2024-2025; stop using immediately if you have this product.
