Device recall
Z-0445-2013: The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix…
FDA device recall · Class II · Diamedix Corporation
Key facts
| Recall number (Z-number) | Z-0445-2013 |
|---|---|
| Recall event | 63410 |
| Product | The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA… |
| Product code | LLL |
| Recalling firm | Diamedix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2014 |
| 510(k) numbers | K970220 |
| 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