Dfi Co., Ltd. 388-25 Gomo-ro Jillye-myeon Gimhae Korea (the Republic Of): Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Recall Summary DFI Co., Ltd. is recalling the One Step P in vitro diagnostic test (REF: 8194), a device used to detect protein or albumin in urine samples. The devices were distributed without FDA premarket clearance or approval, which is required before these medical devices can be sold. The devices were distributed nationwide across the United States, as well as in England.
- Recalling firm
- DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)
- Product
- One Step P in vitro diagnostic test REF: 8194
- 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/b49fb754-8489-474f-ae70-8ba64fbc4f7d