DFI Co., Ltd. recalls

7 recalls.

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