Device recall
Z-0065-2010: CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0065-2010 |
|---|---|
| Recall event | 52964 |
| Product | CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA. Automated 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 | Dec 6, 2010 |
| 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