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DFI Co., Ltd. FDA Recalls

7 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Uric Acid in vitro diagnostic test REF: 31H0PClass IIApr 2, 2026The devices were distributed without required FDA premarket	The devices were distributed without required FDA premarket clearance or approval.	Class IIDevices	Apr 2, 2026
One Step P in vitro diagnostic test REF: 8194Class IIApr 2, 2026The devices were distributed without required FDA premarket	The devices were distributed without required FDA premarket clearance or approval.	Class IIDevices	Apr 2, 2026
One Step 10A in vitro diagnostic testClass IIApr 2, 2026The devices were distributed without required FDA premarket	The devices were distributed without required FDA premarket clearance or approval.	Class IIDevices	Apr 2, 2026
One Step UTI in vitro diagnostic test REF: 3374Class IIApr 2, 2026The devices were distributed without required FDA premarket	The devices were distributed without required FDA premarket clearance or approval.	Class IIDevices	Apr 2, 2026
One Step K in vitro diagnostic test REF: 81A4Class IIApr 2, 2026The devices were distributed without required FDA premarket	The devices were distributed without required FDA premarket clearance or approval.	Class IIDevices	Apr 2, 2026
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407Class IIApr 2, 2026The devices were distributed without required FDA premarket	The devices were distributed without required FDA premarket clearance or approval.	Class IIDevices	Apr 2, 2026
One Step pH in vitro diagnostic test REF: 31I4PClass IIApr 2, 2026The devices were distributed without required FDA premarket	The devices were distributed without required FDA premarket clearance or approval.	Class IIDevices	Apr 2, 2026

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