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

DFI Co., Ltd.: One Step pH in vitro diagnostic test REF: 31I4P

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

Read the official notice at FDA (device) →

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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 pH in vitro diagnostic test REF: 31I4P
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: 08806141303060/ Lot: 250305, 250415, 250509, 250625, 250905
Product quantity
7860 units
Voluntary mandated
Voluntary: Firm initiated
City
Gimhae
Country
Korea (the Republic of)
Event id
98739
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