Device recall
Z-0815-2016: CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description…
FDA device recall · Class III · Lab Vision Corporation
Key facts
| Recall number (Z-number) | Z-0815-2016 |
|---|---|
| Recall event | 73120 |
| Product | CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in… |
| Product code | NJT |
| Recalling firm | Lab Vision Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 24, 2016 |
| FEI number | 3000719701 |
At a glance
- None 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