Device recall
Z-2682-2014: The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative…
FDA device recall · Class II · Nanosphere, Inc.
Key facts
| Recall number (Z-number) | Z-2682-2014 |
|---|---|
| Recall event | 69034 |
| Product | 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), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027… |
| Product code | OZN |
| Recalling firm | Nanosphere, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 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