Device recall
Z-2397-2019: Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully…
FDA device recall · Class II · Phadia Ab
Key facts
| Recall number (Z-number) | Z-2397-2019 |
|---|---|
| Recall event | 83402 |
| Product | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results. |
| Product code | DHB |
| Recalling firm | Phadia Ab |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 12, 2022 |
| 510(k) numbers | K051218 |
| FEI number | 3002807876 |
At a glance
- 1–9 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