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Z-2088-2026Class 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
1064 units
Initiated by
Voluntary: Firm initiated
Reason for recall

The devices were distributed without required FDA premarket clearance or approval.

Product description

One Step P in vitro diagnostic test REF: 8194

Code / lot info

UDI:08806141302025/ Lot: 241023, 250527, 250905

Other recalls SPEQ maps to Documentation & Change Control
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 →