| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00808-1 |
| Product Name/Description |
Unicel DxH Slidemaker Stainer Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)
Software version 3.2
Part Number: PN 775222
ARTG Number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has determined that a fitting installed in a select population of Slidemaker Stainer (SMS) units may not completely seal after being installed. Please note that not all fittings installed may be affected. For those affected, one may observe a slow dripping leak of the staining reagents (methanol, alcohol and buffers) into the spill tray below designed for this purpose. There is no impact to patient results due to this issue.
There is no new or additional safety risk associated with this issue beyond the continued potential of exposure to stain and methanol associated with the handling of these chemicals resulting from a slow dripping leak. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is asking that customers:
1 - Immediately contact your Beckman Coulter representative to schedule a service visit in the event of a leak. Beckman Coulter Field Service Engineers will replace the fitting on the impacted instruments.
2 - Inspect the reagent supply drawer for spills; if necessary, clean up with absorbent materials such as paper towels, and dispose in accordance with your local regulations and laboratory procedures.
3 - Follow best laboratory practices when using the instrument, which includes the use of appropriate personal protective equipment (PPE) to protect the user from exposure.
This action has been closed out on 18/09/2018 |
| Contact Information |
02 9844 6416 - Beckham Coulter Australia |