Device recall
Z-1873-2008: VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed…
FDA device recall · Class II · Sun Biomedical Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-1873-2008 |
|---|---|
| Recall event | 48464 |
| Product | VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. |
| Product code | DJR |
| Recalling firm | Sun Biomedical Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2009 |
| FEI number | 1000526795 |
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