Reported May 13, 2026 · Ongoing
One Step P in vitro diagnostic test REF: 8194
DFI Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DFI Co., Ltd. · 388-25 Gomo-Ro · Gimhae · N/A
Is this the product you have?
- One Step P in vitro diagnostic test REF8194
- Lot codes and dates
- UDI08806141302025/
- Lot
241023250527250905
- Amount recalled
- 1064 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The devices were distributed without required FDA premarket clearance or approval.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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