Device recall
Z-0607-2011: Access Immunoassay Systems, Part Number: 81600; Access 2 Immunoassay Systems…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0607-2011 |
|---|---|
| Recall event | 56752 |
| Product | Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Access Immunoassay Systems, Part Number A30260; UniCel DxC 600i, Part Number: A25656; UniCel DxC 660i… |
| Product code | JJE |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 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