Device recall
Z-2168-2014: Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test…
FDA device recall · Class III · Nanosphere, Inc.
Key facts
| Recall number (Z-number) | Z-2168-2014 |
|---|---|
| Recall event | 68708 |
| Product | Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB)… |
| Product code | OZN |
| Recalling firm | Nanosphere, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 22, 2015 |
| 510(k) numbers | K123197 |
| 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