Dfi Co., Ltd. 388-25 Gomo-ro Jillye-myeon Gimhae Korea (the Republic Of): Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Recall Summary DFI Co., Ltd. is recalling the One Step 10A drug abuse test kit because it was sold in the United States without the FDA's required approval. The product was distributed nationwide across most U.S. states, as well as in Florida, Pennsylvania, and England.
- Recalling firm
- DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)
- Product
- One Step 10A in vitro diagnostic test
- Reason
- The devices were distributed without required FDA premarket clearance or approval.
- 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/42106544-2b5a-470f-9591-993fd62c306e