FDAFDA · Food and drugs·Recall number Z-2088-2026
One Step P in vitro diagnostic test REF: 8194
Published May 13, 2026 · Recall initiated: April 2, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The devices were distributed without required FDA premarket clearance or approval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DFI Co., Ltd.
- Distributor
- Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- Lot
- UDI:08806141302025/ Lot: 241023, 250527, 250905
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Korea (the Republic of)
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