Device recall
Z-0193-2013: Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to…
FDA device recall · Class III · Clinical Diagnostic Solutions
Key facts
| Recall number (Z-number) | Z-0193-2013 |
|---|---|
| Recall event | 63094 |
| Product | Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. |
| Product code | JPK |
| Recalling firm | Clinical Diagnostic Solutions |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 14, 2014 |
| 510(k) numbers | K024173 |
| FEI number | 3002684533 |
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