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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 Beckman Coulter Australia Pty Ltd
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