HIGH
One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
DFI Co.
The devices
HIGH
Uric Acid in vitro diagnostic test REF: 31H0P
The devices were distributed without required FDA premarket clearance or approval.
Quick Facts at a Glance
- Recall Date
- April 2, 2026
- Hazard Level
- HIGH
- Brand
- DFI Co.
- Geographic Scope
- 1 states
Hazard Information
The devices were distributed without required FDA premarket clearance or approval.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact DFI Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
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Full Description
Uric Acid in vitro diagnostic test REF: 31H0P. Reason: The devices were distributed without required FDA premarket clearance or approval.. Classification: Class II. Quantity: 59815 units. Distribution: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
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Safety Guide
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Product Classification
Product Details
Brand
Categories
Model Numbers
UDI: 08806141303077/ Lot: 241023
250415
250509
250617
250905
Affected States
ALL
Report Date
May 13, 2026
Source Agency
FDA - Medical DevicesRecall Status
ACTIVE
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