Device recall
Z-2330-2016: EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for…
FDA device recall · Class II · Dako Denmark A/S
Key facts
| Recall number (Z-number) | Z-2330-2016 |
|---|---|
| Recall event | 74608 |
| Product | EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments. |
| Product code | LDT |
| Recalling firm | Dako Denmark A/S |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 13, 2016 |
| FEI number | 3002806778 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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