Device recall
Z-1276-2018: Phadia Prime software, article number 12-4101-00, as used in combination with…
FDA device recall · Class II · Phadia Ab
Key facts
| Recall number (Z-number) | Z-1276-2018 |
|---|---|
| Recall event | 79438 |
| Product | Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4. |
| Product code | DHB |
| Recalling firm | Phadia Ab |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 6, 2019 |
| 510(k) numbers | K151029 |
| 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