Device recall
Z-0472-2019: COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II…
FDA device recall · Class I · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0472-2019 |
|---|---|
| Recall event | 81039 |
| Product | COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software |
| Product code | GKZ |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 30, 2024 |
| 510(k) numbers | K963263, K990172 |
| FEI number | 2050012 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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