Device recall
Z-0884-05: IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no…
FDA device recall · Class III · International Remote Imaging Systems Inc
Key facts
| Recall number (Z-number) | Z-0884-05 |
|---|---|
| Recall event | 32036 |
| Product | IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074. |
| Product code | JJW |
| Recalling firm | International Remote Imaging Systems Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 7, 2012 |
| 510(k) numbers | K945913 |
| 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