Device recall
Z-2441-2015: iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050…
FDA device recall · Class II · Iris Diagnostics
Key facts
| Recall number (Z-number) | Z-2441-2015 |
|---|---|
| Recall event | 71780 |
| Product | iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. |
| Product code | KQO |
| Recalling firm | Iris Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 26, 2016 |
| 510(k) numbers | K101852 |
| 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