Device recall
Z-2090-2015: BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD…
FDA device recall · Class III · BD Biosciences, Systems & Reagents
Key facts
| Recall number (Z-number) | Z-2090-2015 |
|---|---|
| Recall event | 71502 |
| Product | BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of… |
| Product code | GKZ |
| Recalling firm | BD Biosciences, Systems & Reagents |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 12, 2016 |
| 510(k) numbers | K040725, K973483 |
| 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