Device recall
Z-1570-2016: BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes…
FDA device recall · Class II · Becton, Dickinson and Company, BD Biosciences
Key facts
| Recall number (Z-number) | Z-1570-2016 |
|---|---|
| Recall event | 73748 |
| Product | BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount… |
| Product code | GKZ |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 26, 2017 |
| 510(k) numbers | K970836 |
| 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