Device recall
Z-1341-2018: AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1341-2018 |
|---|---|
| Recall event | 79381 |
| Product | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland. |
| Product code | OYE |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 27, 2019 |
| 510(k) numbers | K141932 |
| FEI number | 2050012 |
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