Device recall
Z-0306-2009: CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0306-2009 |
|---|---|
| Recall event | 49397 |
| Product | CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells. |
| Product code | GKZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 6, 2011 |
| 510(k) numbers | K051215 |
| 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