Device recall
Z-1703-2020: The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives…
FDA device recall · Class II · Sysmex America, Inc.
Key facts
| Recall number (Z-number) | Z-1703-2020 |
|---|---|
| Recall event | 85254 |
| Product | The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in… |
| Product code | LXG |
| Recalling firm | Sysmex America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2021 |
| FEI number | 3009711478 |
At a glance
- None 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