Warning
DFI Co. Recalls QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2085-2026Medical Device
DFI Co. Recalls QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
DFI Co., Ltd. · Class II — Moderate Risk
Product Description
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Reason for Recall
The devices were distributed without required FDA premarket clearance or approval.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. DFI Co., Ltd. initiated the recall on April 2, 2026 affecting 6398 units. The devices were distributed without required FDA premarket clearance or approval. The product was distributed internationally, including the United States. Consumers should check their purchases and discontinue use of any affected product. Contact DFI Co., Ltd. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.