Device recall
Z-1426-2010: REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an…
FDA device recall · Class II · American Diagnostica, Inc.
Key facts
| Recall number (Z-number) | Z-1426-2010 |
|---|---|
| Recall event | 54858 |
| Product | REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma. |
| Product code | GGP |
| Recalling firm | American Diagnostica, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 29, 2016 |
| 510(k) numbers | K013168 |
| FEI number | 1220602 |
At a glance
- 1–9 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