Device recall
Z-0541-05: The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with…
FDA device recall · Class III · Diamedix Corporation
Key facts
| Recall number (Z-number) | Z-0541-05 |
|---|---|
| Recall event | 31078 |
| Product | The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert. |
| Product code | LHL |
| Recalling firm | Diamedix Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 3, 2012 |
| 510(k) numbers | K970149 |
| FEI number | 1044713 |
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