DFI Co., Ltd. recalls
7 recalls filed under DFI Co., Ltd.. The most recent was published May 13, 2026.
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Class II · 6 months ago
DFI Co., Ltd. One Step UTI in vitro diagnostic test REF: 3374 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
DFI Co., Ltd. One Step 10A in vitro diagnostic test recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
DFI Co., Ltd. One Step pH in vitro diagnostic test REF: 31I4P recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
DFI Co., Ltd. One Step P in vitro diagnostic test REF: 8194 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
DFI Co., Ltd. Qucare Total Cholesterol in vitro diagnostic test REF: 6407 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
DFI Co., Ltd. Uric Acid in vitro diagnostic test REF: 31H0P recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
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Class II · 6 months ago
DFI Co., Ltd. One Step K in vitro diagnostic test REF: 81A4 recall: The devices were distributed without required FDA premarket clearance
The devices were distributed without required FDA premarket clearance or approval.
About this page
DFI Co., Ltd. appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.