Device recall
Z-2087-2026: One Step K in vitro diagnostic test REF: 81A4
FDA device recall · Class II · DFI Co., Ltd.
Key facts
| Recall number (Z-number) | Z-2087-2026 |
|---|---|
| Recall event | 98739 |
| Product | One Step K in vitro diagnostic test REF: 81A4 |
| Product code | JIN |
| Recalling firm | DFI Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3005841640 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database