Device recall
Z-0516-2020: UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II…
FDA device recall · Class II · Beckman Coulter, Inc.
Key facts
| Recall number (Z-number) | Z-0516-2020 |
|---|---|
| Recall event | 84186 |
| Product | UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean… |
| Product code | GKZ |
| Recalling firm | Beckman Coulter, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2021 |
| 510(k) numbers | K140911 |
| FEI number | 3000203293 |
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