Device recall
Z-2398-2012: The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the…
FDA device recall · Class II · Bio-Rad Laboratories
Key facts
| Recall number (Z-number) | Z-2398-2012 |
|---|---|
| Recall event | 62850 |
| Product | The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is… |
| Product code | LOM |
| Recalling firm | Bio-Rad Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2012 |
| PMA numbers | P050048 |
| 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