Device recall
Z-1623-2011: CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1623-2011 |
|---|---|
| Recall event | 54468 |
| Product | CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA Medical device component. The CELL-DYN 4000 System is a multiparameter automated hematology analyzer designed… |
| Product code | GKZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 11, 2011 |
| 510(k) numbers | K961439 |
| 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