Device recall
Z-0808-2016: Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is…
FDA device recall · Class II · Leica Microsystems, Inc.
Key facts
| Recall number (Z-number) | Z-0808-2016 |
|---|---|
| Recall event | 72802 |
| Product | Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of… |
| Product code | NJT |
| Recalling firm | Leica Microsystems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2017 |
| 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