UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical System. In vitro diagnostic medical devices (IVDs) 의 리콜

Recall

RC-2013-RN-00107-1

Class II

2013-02-06

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00107-1

Improper tubing installing by the customer during routine maintenance may prevent the dxi and dxc systems from washing reaction vessels properly and may lead to erroneous test results. the reason for the customer mis-routing of instrument tubing was determined to be two fold:- the mechanical controls on the instrument were insufficient to prevent incorrect routing of the aspirate and dispense tubing.- the instructional drawings in the service documentation were difficult for the customer to understand.This recall action was not notified to the tga before it was initiated by beckman coulter australia.

Beckman Coulter Australia is advising that all affected systems were corrected with a new design that provided mechanical controls to reduce the potential for tubing installation errors. Also, updated service documentation with clearer instructions were distributed to affected customers.