Device recall
Z-2817-2015: CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog…
FDA device recall · Class III · Becton, Dickinson and Company, BD Biosciences
Key facts
| Recall number (Z-number) | Z-2817-2015 |
|---|---|
| Recall event | 72071 |
| Product | CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and… |
| Product code | GKZ |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 9, 2016 |
| 510(k) numbers | K900802 |
| FEI number | 2916837 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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