Dfi Co., Ltd. 388-25 Gomo-ro Jillye-myeon Gimhae Korea (the Republic Of): Nitroprusside, Ketones (urinary, Non-quant.)
Recall Summary DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (model 81A4) that were sold nationwide in the US, as well as in England, because they were distributed without FDA premarket clearance or approval. The test is used to detect nitroprusside and urinary ketones. This is a Class I recall, the most serious classification.
- Recalling firm
- DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)
- Product
- One Step K in vitro diagnostic test REF: 81A4
- 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/82377672-5e79-4dae-9c39-f0fdc9dde237