Device recall
Z-0717-2014: Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica…
FDA device recall · Class II · Leica Biosystems Newcastle Ltd.
Key facts
| Recall number (Z-number) | Z-0717-2014 |
|---|---|
| Recall event | 66030 |
| Product | Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphate… |
| Product code | NJT |
| Recalling firm | Leica Biosystems Newcastle Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 14, 2017 |
| FEI number | 3004859032 |
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