Device recall
Z-2431-2012: Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of…
FDA device recall · Class II · Sekisui Diagnostics Llc
Key facts
| Recall number (Z-number) | Z-2431-2012 |
|---|---|
| Recall event | 63016 |
| Product | Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro… |
| Product code | GGP |
| Recalling firm | Sekisui Diagnostics Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2016 |
| 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