Device recall
Z-0398-06: ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12…
FDA device recall · Class III · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-0398-06 |
|---|---|
| Recall event | 34266 |
| Product | ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, distributed by Abbot Laboratories, Irving, TX. |
| Product code | JJE |
| Recalling firm | Abbott Laboratories, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 25, 2007 |
| 510(k) numbers | K980367 |
| FEI number | 1628664 |
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