FDA DevicesClass II
One Step P in vitro diagnostic test REF: 8194
Published: May 13, 2026Recall ID: Z-2088-2026Category: devicesCountry: US
Reason for Recall / Hazard
The devices were distributed without required FDA premarket clearance or approval.
Product Description & Identification
One Step P in vitro diagnostic test REF: 8194
Affected Products
One Step P in vitro diagnostic test REF: 8194
Additional Source Details
| Field | Value |
|---|---|
| City | Gimhae |
| Event id | 98739 |
| Address 1 | 388-25 Gomo-Ro |
| Address 2 | Jillye-Myeon |
| Code info | UDI:08806141302025/ Lot: 241023, 250527, 250905 |
| Postal code | N/A |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 1064 units |
| Reason for recall | The devices were distributed without required FDA premarket clearance or approval. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260402 |
| Initial firm notification | Letter |
| Center classification date | 20260506 |
Overview
- Recalling FirmDFI Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of FL, PA and the country of England.