Device recall
Z-0755-2007: DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the…
FDA device recall · Class III · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-0755-2007 |
|---|---|
| Recall event | 37691 |
| Product | DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285 |
| Product code | LLM |
| Recalling firm | Diasorin Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 15, 2007 |
| 510(k) numbers | K946158 |
| 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