Dfi Co., Ltd. 388-25 Gomo-ro Jillye-myeon Gimhae Korea (the Republic Of): Acid, Uric, Uricase (colorimetric)
Recall Summary DFI Co., Ltd.'s Uric Acid in vitro diagnostic test (model 31H0P) is being recalled because it was sold in the US and England without FDA premarket clearance or approval. The test was distributed nationwide across the United States, as well as in Florida, Pennsylvania, and England. 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
- Uric Acid in vitro diagnostic test REF: 31H0P
- 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/fcbef532-b0b3-431f-9b92-e23396483a76