FDAHealthApril 2, 2026
DFI Co., Ltd. — QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
⚠️ The devices were distributed without required FDA premarket clearance or approval.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 2, 2026
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
What's affected?
- Product
- QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
- Brand
- DFI Co., Ltd.
- Lot code
- BS032501
Additional details
UDI: 08806141303060/ Lot: BS032501, BS042502, BS062501, BS062502, BS082501
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6398 units.
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