Device recall
Z-1313-06: Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200
FDA device recall · Class II · Beckman Coulter Inc
Key facts
| Recall number (Z-number) | Z-1313-06 |
|---|---|
| Recall event | 35630 |
| Product | Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200 |
| Product code | DHX |
| Recalling firm | Beckman Coulter Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2012 |
| 510(k) numbers | K981985 |
| FEI number | 2050012 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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