Device recall
Z-1439-06: BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and…
FDA device recall · Class II · Biogenex Laboratories
Key facts
| Recall number (Z-number) | Z-1439-06 |
|---|---|
| Recall event | 35614 |
| Product | BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583 |
| Product code | MVU |
| Recalling firm | Biogenex Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2006 |
| FEI number | 2936532 |
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