DFI Co., Ltd. recalls One Step 10A in vitro diagnostic test
- Recalling company
- DFI Co., Ltd.
- Product
- One Step 10A in vitro diagnostic test
- Reason
- The devices were distributed without required FDA premarket clearance or approval.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 2, 2026
- Reported
- May 13, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- Status
- Ongoing
- Quantity
- 6533 units
- Lot / codes
- UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905
- Company location
- Gimhae
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2082-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2082-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.