Device recall
Z-2708-2014: Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480…
FDA device recall · Class II · Dako North America Inc.
Key facts
| Recall number (Z-number) | Z-2708-2014 |
|---|---|
| Recall event | 69191 |
| Product | Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell… |
| Product code | KPA |
| Recalling firm | Dako North America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 3, 2015 |
| FEI number | 2022180 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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