Device recall
Z-1328-2013: Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number…
FDA device recall · Class II · Iris Diagnostics
Key facts
| Recall number (Z-number) | Z-1328-2013 |
|---|---|
| Recall event | 64910 |
| Product | Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series. |
| Product code | JJW |
| Recalling firm | Iris Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 27, 2014 |
| 510(k) numbers | K832713 |
| FEI number | 2023446 |
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