Device recall
Z-1620-2010: Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs…
FDA device recall · Class III · Bio-Rad Laboratories
Key facts
| Recall number (Z-number) | Z-1620-2010 |
|---|---|
| Recall event | 49126 |
| Product | Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... Bio-Rad Laboratories Redmond, WA 98052" For the qualitative detection of antibody to Hepatitis B Surface Antigen (anti-HBs) in Human Serum and EDTA or citrated… |
| Product code | LOM |
| Recalling firm | Bio-Rad Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 20, 2010 |
| 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