One Step 10A in vitro diagnostic test recall (DFI Co., Ltd.)
Medical deviceClass IIOngoing
Summary: DFI Co., Ltd. is recalling One Step 10A in vitro diagnostic test. Reason: The devices were distributed without required FDA premarket clearance or approval.
What is being recalled
One Step 10A in vitro diagnostic test
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: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 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-2082-2026 |
| 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 | 6533 units |
More recalls from DFI Co., Ltd. · all medical device recalls · recalls from April 2026