Device recall
Z-1354-2019: Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol…
FDA device recall · Class II · Abbott Ireland Diagnostics Division
Key facts
| Recall number (Z-number) | Z-1354-2019 |
|---|---|
| Recall event | 82129 |
| Product | Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer. |
| Product code | CHP |
| Recalling firm | Abbott Ireland Diagnostics Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2020 |
| FEI number | 3005094123 |
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