← FDA ENFORCEMENT
Z-2085-2026Class II
DFI Co., Ltd.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
DFI Co., Ltd.
Product type
Device
Status
Ongoing
Report date
2026-05-13
Distribution
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Product quantity
6398 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
The devices were distributed without required FDA premarket clearance or approval.
Product description
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Code / lot info
UDI: 08806141303060/ Lot: BS032501, BS042502, BS062501, BS062502, BS082501
Other recalls SPEQ maps to Documentation & Change Control
2026-10-21Class IIIn2bones USA, LLC2026-10-21Class IIW L Gore & Associates, Inc.2026-10-21Class IIEthicon, LLC2026-10-21Class IIBoston Scientific Corporation
See all Documentation & Change Control recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →