| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01021-1 |
| Product Name/Description |
UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD)
UniCel DxH 800 Coulter Cellular Analysis System
Product Number: 629029
UniCel DxH 600 Coulter Cellular Analysis System
Product Number: B23858 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
An internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamber or Probe Waste Chamber. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised that if they experience a "Vent/overflow chamber detected overflow" error message, the three samples prior to the error message must be reviewed. Physical contact with leaks should be avoided by continuing to use protective equipment.
A service representative will contact each customer to schedule an on-site visit for check valve inspection of any affected valves. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |