Device recall
Z-0803-2011: ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing.
FDA device recall · Class II · Instrumentation Laboratory Co.
Key facts
| Recall number (Z-number) | Z-0803-2011 |
|---|---|
| Recall event | 57274 |
| Product | ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing. |
| Product code | JPA |
| Recalling firm | Instrumentation Laboratory Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 23, 2013 |
| 510(k) numbers | K060162 |
| FEI number | 1217183 |
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