Device product
One Step UTI in vitro diagnostic test REF: 3374
Z-2083-2026
Product summary
- Firm
- DFI Co., Ltd.
- Event
- Event 98739
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2423 units
- Official record key
device-enforcement:Z-2083-2026
Official wording
Reason: The devices were distributed without required FDA premarket clearance or approval.
Code information: UDI: 08806141303480/ Lot: 241023, 250625, 250905
Distribution pattern: Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Derived failure modes
-
Unknown
The devices were distributed without required FDA premarket clearance or approval.