Device recall
Z-0609-06: Test kit used in the assessment of breast cancer patients for whom Herceptin…
FDA device recall · Class II · Biogenex Laboratories
Key facts
| Recall number (Z-number) | Z-0609-06 |
|---|---|
| Recall event | 34586 |
| Product | Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Automated; Model number: AM134-10MP; Lot Numbers: AM134P1005 |
| Product code | MVC |
| Recalling firm | Biogenex Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 23, 2006 |
| PMA numbers | P040030 |
| FEI number | 2936532 |
At a glance
- None 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