Device recall
Z-0557-06: The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software…
FDA device recall · Class II · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-0557-06 |
|---|---|
| Recall event | 33128 |
| Product | The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1). |
| Product code | LJY |
| Recalling firm | Diasorin Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2006 |
| 510(k) numbers | K991274 |
| FEI number | 2182595 |
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