Device recall
Z-0619-2013: Analyzing system consists of a small and portable analyzer and plastic…
FDA device recall · Class III · HemoCue AB
Key facts
| Recall number (Z-number) | Z-0619-2013 |
|---|---|
| Recall event | 63825 |
| Product | Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are… |
| Product code | JIQ |
| Recalling firm | HemoCue AB |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 14, 2013 |
| 510(k) numbers | K053253 |
| FEI number | 3003044483 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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