Device recall
Z-0776-05: DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody…
FDA device recall · Class III · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-0776-05 |
|---|---|
| Recall event | 31735 |
| Product | DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy |
| Product code | LOL |
| Recalling firm | Diasorin Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 22, 2006 |
| PMA numbers | P890014 |
| FEI number | 2182595 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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