Device recall
Z-2559-2014: Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of…
FDA device recall · Class III · Nanosphere, Inc.
Key facts
| Recall number (Z-number) | Z-2559-2014 |
|---|---|
| Recall event | 68710 |
| Product | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test. |
| Product code | NTI |
| Recalling firm | Nanosphere, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 2, 2015 |
| 510(k) numbers | K120466 |
| 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