Dfi Co., Ltd. 388-25 Gomo-ro Jillye-myeon Gimhae Korea (the Republic Of): Test, Urine Leukocyte
Recall Summary DFI Co., Ltd. is recalling One Step UTI in vitro diagnostic test kits (model 3374) that were sold nationwide in the US, Florida, Pennsylvania, and England. The kits were distributed without required FDA approval before being marketed. This is a Class I recall, meaning the product poses a serious health risk.
- Recalling firm
- DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)
- Product
- One Step UTI in vitro diagnostic test REF: 3374
- Reason
- The devices were distributed without required FDA premarket clearance or approval.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-02
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/be175bf2-5c57-47be-8cf6-a62446b8cb44