One Step P in vitro diagnostic test REF: 8194 recall (DFI Co., Ltd.)
Medical deviceClass IIOngoing
Summary: DFI Co., Ltd. is recalling One Step P in vitro diagnostic test REF: 8194. Reason: The devices were distributed without required FDA premarket clearance or approval.
What is being recalled
One Step P in vitro diagnostic test REF: 8194
Why
The devices were distributed without required FDA premarket clearance or approval.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England. (states named: Florida, Pennsylvania)
How to tell if yours is affected
UDI:08806141302025/ Lot: 241023, 250527, 250905
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2088-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 2, 2026 |
| Reported | May 13, 2026 |
| Company | DFI Co., Ltd. |
| Company location | Gimhae, Korea (the Republic of) |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1064 units |
More recalls from DFI Co., Ltd. · all medical device recalls · recalls from April 2026