Device recall
Z-1703-2011: Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1703-2011 |
|---|---|
| Recall event | 51955 |
| Product | Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories. |
| Product code | GKZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2011 |
| 510(k) numbers | K991605 |
| 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