Dfi Co., Ltd. 388-25 Gomo-ro Jillye-myeon Gimhae Korea (the Republic Of): Enzymatic Esterase--oxidase, Cholesterol
Recall Summary DFI Co., Ltd.'s QUCARE Total Cholesterol test device (REF: 6407) is being recalled because it was sold in the United States without FDA approval. The device was distributed nationwide, as well as in England, and is used to measure cholesterol levels in blood samples.
- Recalling firm
- DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)
- Product
- QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
- 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/8c751ee2-6c53-4ad1-89ee-f69264122be4