Device recall
Z-0172-2023: BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of…
FDA device recall · Class II · Becton, Dickinson and Company, BD Biosciences
Key facts
| Recall number (Z-number) | Z-0172-2023 |
|---|---|
| Recall event | 90866 |
| Product | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes 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 Tubes can be used with the BD FACS Loader. |
| Product code | GKZ |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K090967 |
| 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