Device recall
Z-0065-2008: Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test…
FDA device recall · Class III · Bio-Rad Laboratories
Key facts
| Recall number (Z-number) | Z-0065-2008 |
|---|---|
| Recall event | 44881 |
| Product | Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA. |
| Product code | LOM |
| Recalling firm | Bio-Rad Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 15, 2007 |
| PMA numbers | P060034 |
| FEI number | 3008272466 |
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