Device recall
Z-1074-2019: CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1074-2019 |
|---|---|
| Recall event | 82240 |
| Product | CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory. |
| Product code | GKZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2021 |
| 510(k) numbers | K081495 |
| FEI number | 2919069 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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