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
See all Documentation & Change Control recalls →Data: U.S. FDA openFDA enforcement API. 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.