Device recall
Z-1398-2009: Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1398-2009 |
|---|---|
| Recall event | 51207 |
| Product | Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagnostics Division, Santa Clara, CA. Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two… |
| Product code | GKZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2010 |
| 510(k) numbers | K061667 |
| 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