Device recall
Z-0664-2019: Alinity i TSH Reagent Kit, List Number 07P4830
FDA device recall · Class II · Abbott Ireland Diagnostics Division
Key facts
| Recall number (Z-number) | Z-0664-2019 |
|---|---|
| Recall event | 81632 |
| Product | Alinity i TSH Reagent Kit, List Number 07P4830 |
| Product code | JLW |
| Recalling firm | Abbott Ireland Diagnostics Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2021 |
| 510(k) numbers | K983442 |
| FEI number | 3005094123 |
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