Device recall
Z-2124-2012: IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part…
FDA device recall · Class III · Iris Diagnostics
Key facts
| Recall number (Z-number) | Z-2124-2012 |
|---|---|
| Recall event | 62555 |
| Product | IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only. |
| Product code | JJW |
| Recalling firm | Iris Diagnostics |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 27, 2014 |
| 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