Device recall
Z-0673-2020: BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is…
FDA device recall · Class II · Leica Microsystems, Inc.
Key facts
| Recall number (Z-number) | Z-0673-2020 |
|---|---|
| Recall event | 84301 |
| Product | BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse… |
| Product code | NJT |
| Recalling firm | Leica Microsystems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3000210133 |
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