Dfi Co., Ltd. 388-25 Gomo-ro Jillye-myeon Gimhae Korea (the Republic Of): Dye-indicator, Ph (urinary, Non-quantitative)
Recall Summary DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test (REF: 31I4P), a urine pH test strip, because it was sold in the United States without the required FDA approval. The product was distributed nationwide across most U.S. states, with specific documented distribution in Florida, Pennsylvania, and England.
- Recalling firm
- DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)
- Product
- One Step pH in vitro diagnostic test REF: 31I4P
- 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/6a1daafb-6c80-4e1a-bdf3-0d4dbeabd1b4