Device recall
Z-1676-2015: D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA…
FDA device recall · Class III · Biocare Medical, LLC
Key facts
| Recall number (Z-number) | Z-1676-2015 |
|---|---|
| Recall event | 71229 |
| Product | D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed… |
| Product code | NJT |
| Recalling firm | Biocare Medical, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 4, 2015 |
| FEI number | 3004140393 |
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