Device recall
Z-1261-2015: Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100)…
FDA device recall · Class II · Dako North America Inc.
Key facts
| Recall number (Z-number) | Z-1261-2015 |
|---|---|
| Recall event | 70558 |
| Product | Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use. |
| Product code | KPA |
| Recalling firm | Dako North America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2016 |
| 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