Device recall
Z-0313-06: EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent)…
FDA device recall · Class II · Dakocytomation California Inc
Key facts
| Recall number (Z-number) | Z-0313-06 |
|---|---|
| Recall event | 33957 |
| Product | EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4003 |
| Product code | NJT |
| Recalling firm | Dakocytomation California Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2007 |
| FEI number | 2022180 |
At a glance
- None Linked 510(k)s
- 10–99 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