Device recall
Z-1469-2020: VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in…
FDA device recall · Class II · The Binding Site Group, Ltd.
Key facts
| Recall number (Z-number) | Z-1469-2020 |
|---|---|
| Recall event | 84899 |
| Product | VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in… |
| Product code | GRP |
| Recalling firm | The Binding Site Group, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 20, 2022 |
| FEI number | 3002808340 |
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