Device recall
Z-2578-2023: ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in…
FDA device recall · Class II · Instrumentation Laboratory
Key facts
| Recall number (Z-number) | Z-2578-2023 |
|---|---|
| Recall event | 92831 |
| Product | ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3)… |
| Product code | GKP |
| Recalling firm | Instrumentation Laboratory |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150877 |
| 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