Device recall
Z-2684-2014: The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene…
FDA device recall · Class II · Nanosphere, Inc.
Key facts
| Recall number (Z-number) | Z-2684-2014 |
|---|---|
| Recall event | 69034 |
| Product | The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of… |
| Product code | OCC |
| Recalling firm | Nanosphere, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2015 |
| 510(k) numbers | K103209 |
| FEI number | 3006028115 |
At a glance
- 1–9 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