Device recall
Z-2378-2016: BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label…
FDA device recall · Class III · Becton, Dickinson and Company, BD Biosciences
Key facts
| Recall number (Z-number) | Z-2378-2016 |
|---|---|
| Recall event | 74788 |
| Product | BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color… |
| Product code | GKZ |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 1, 2017 |
| 510(k) numbers | K071143 |
| 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