Device recall
Z-2064-2014: ACL TOP 500 CTS, automated coagulation laboratory instrument.
FDA device recall · Class II · Instrumentation Laboratory Co.
Key facts
| Recall number (Z-number) | Z-2064-2014 |
|---|---|
| Recall event | 68578 |
| Product | ACL TOP 500 CTS, automated coagulation laboratory instrument. |
| Product code | GKP |
| Recalling firm | Instrumentation Laboratory Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2017 |
| 510(k) numbers | K033141 |
| FEI number | 1217183 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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