Device recall
Z-1315-2015: Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform…
FDA device recall · Class II · Leica Microsystems, Inc.
Key facts
| Recall number (Z-number) | Z-1315-2015 |
|---|---|
| Recall event | 70090 |
| Product | Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence… |
| Product code | NJT |
| Recalling firm | Leica Microsystems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 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