Device recall
Z-0863-2010: Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers…
FDA device recall · Class I · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0863-2010 |
|---|---|
| Recall event | 54344 |
| Product | Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel DxC 800 PRO); A59102 (UniCel DxC 880i); A64903 (UniCel DxC 680i); A64871 (UniCel DxC 660i); A64871… |
| Product code | JJE |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 17, 2012 |
| 510(k) numbers | K042291, K060256 |
| 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