Device recall
Z-3181-2011: Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic…
FDA device recall · Class III · Leica Microsystems, Inc.
Key facts
| Recall number (Z-number) | Z-3181-2011 |
|---|---|
| Recall event | 59677 |
| Product | Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The CDX2 (AMT28) monoclonal antibody is… |
| Product code | NJT |
| Recalling firm | Leica Microsystems, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 9, 2011 |
| 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