FDA Enforcement
Class II
Ongoing
One Step UTI in vitro diagnostic test REF: 3374
Recall: Z-2083-2026
·
Reported May 13, 2026
Enforcement
- Recall Number
- Z-2083-2026
- Event ID
- 98739
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- DFI Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 13, 2026
- Initiation Date
- April 2, 2026
- Classification Date
- May 6, 2026
- Address
- 388-25 Gomo-Ro, Jillye-Myeon, Gimhae, N/A, Korea (the Republic of)
Description
One Step UTI in vitro diagnostic test REF: 3374
Reason
The devices were distributed without required FDA premarket clearance or approval.
Code Info
UDI: 08806141303480/ Lot: 241023, 250625, 250905
Distribution
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Quantity
2423 units