Device recall
Z-0463-2013: Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the…
FDA device recall · Class II · Sekisui Diagnostics Llc
Key facts
| Recall number (Z-number) | Z-0463-2013 |
|---|---|
| Recall event | 63615 |
| Product | Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity… |
| Product code | GGP |
| Recalling firm | Sekisui Diagnostics Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 8, 2013 |
| 510(k) numbers | K063323 |
| 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