| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00627-1 |
| Product Name/Description |
BD FACSCanto 10 colour configuration (Cytometer). An in vitro diagnostic medical device (IVD)
Serial Number: V65733800038
ARTG Number: 188752 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
18/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
BD has determined that there is a problem with the laser cooling fans and the fluidics cart internal fan impacting BD FACSCanto. The instrument laser cooling fans and the internal fan of the associated fluidics cart are non-operational potentially affecting the life os the laser of the instrument. Both problems are caused by a reversed wiring configuration that occurred during manufacturing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A BD service representative will contact the customer to arrange for correction. This action has been closed-out on 18/02/2016. |
| Contact Information |
02 8875 7165 - BD National Service Manager |