Device recall
Z-1000-2015: CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single…
FDA device recall · Class II · BD Biosciences, Systems & Reagents
Key facts
| Recall number (Z-number) | Z-1000-2015 |
|---|---|
| Recall event | 70107 |
| Product | CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions. |
| Product code | GKL |
| Recalling firm | BD Biosciences, Systems & Reagents |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 23, 2016 |
| 510(k) numbers | K904390 |
| FEI number | 2916837 |
At a glance
- 1–9 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