⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

DFI Co., Ltd.: One Step K in vitro diagnostic test REF: 81A4

Medical DevicesSource: FDA (device) · Date: 2026-05-13

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
DFI Co., Ltd.
Product
One Step K in vitro diagnostic test REF: 81A4
Reason / hazard
The devices were distributed without required FDA premarket clearance or approval.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Recall initiated
2026-04-02
Code info
UDI:08806141302650/ Lot: 241023, 250625, 250905
Product quantity
761 units
Voluntary mandated
Voluntary: Firm initiated
City
Gimhae
Country
Korea (the Republic of)
Event id
98739
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