Device recall
Z-1619-2011: GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1619-2011 |
|---|---|
| Recall event | 56746 |
| Product | GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640; SYNCHRON and UniCel Systems and Part Numbers: Synchron LX20, Part Number: 466200, Synchron LX20 PRO, Part Number: 476100, Synchron LXI 725, Part Number: 476501, UniCel DxC 600, Part… |
| Product code | CEM |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 17, 2013 |
| 510(k) numbers | K011213, K023049, K042291, K060256, K883181 |
| 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