Device recall
Z-1383-2008: Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in…
FDA device recall · Class II · Nanosphere, Inc.
Key facts
| Recall number (Z-number) | Z-1383-2008 |
|---|---|
| Recall event | 46882 |
| Product | Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 60062 |
| Product code | ODW |
| Recalling firm | Nanosphere, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2010 |
| 510(k) numbers | K070804 |
| FEI number | 3006028115 |
At a glance
- 1–9 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