UniCel DxC Synchron Systems No Foam Reagent (used with the UniCel DxC Synchron Clinical System). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00900-1

Class II

2016-07-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00900-1

Beckman coulter has identified an incompatibility between no foam dxc reagent (ref b64130) and the dxc hydropneumatic parts associated with no foam delivery. dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. over time, this incompatibility may lead to:- breaks in no foam cap assembly- cracks in no foam waste collector; and- seepage outside no foam tubingthis incompatibility does not affect no foam’s ability to perform its function and there is no impact to patient results. however, this issue may lead to cracks in the waste collector which may stop instrument operation due to vacuum error, and potentially lead to biohazardous waste exposure. this may lead to a delay in patient results. cracks in the no foam cap and seepage from the no foam tubing may lead to exposure to no foam. there have been no reports of injuries as a result of this issue.

Beckman Coulter is advising users to continue to use No Foam (Ref: B64130) until a replacement No Foam (Ref; 469110) has been received. Once the replacement No Foam has been received, remaining stocks of No Foam (Ref: B64130) should be discarded.