Device recall
Z-2208-2019: Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay…
FDA device recall · Class II · Abbott Ireland Diagnostics Division
Key facts
| Recall number (Z-number) | Z-2208-2019 |
|---|---|
| Recall event | 83341 |
| Product | Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer. |
| Product code | DBF |
| Recalling firm | Abbott Ireland Diagnostics Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 25, 2021 |
| 510(k) numbers | K983759 |
| FEI number | 3005094123 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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