Device recall
Z-0856-2010: UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0856-2010 |
|---|---|
| Recall event | 53679 |
| Product | UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte… |
| Product code | JJE |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2012 |
| 510(k) numbers | K023764, 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