Device recall
Z-2203-2017: Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic…
FDA device recall · Class II · Cell Marque Corporation
Key facts
| Recall number (Z-number) | Z-2203-2017 |
|---|---|
| Recall event | 77209 |
| Product | Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent |
| Product code | NYQ |
| Recalling firm | Cell Marque Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 7, 2017 |
| FEI number | 3000718726 |
At a glance
- None Linked 510(k)s
- 10–99 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