DxH 500 Open-Vial Haematology System, with software version 1.0.2 and 1.1. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-01401-1

Class II

2017-11-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01401-1

An internal investigation has identified that if the bleach cycle is interrupted or aborted, the dxh 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. should a bleach cycle get interrupted, the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected. this may result in incorrect patient results.There have been no reports of injuries as a result of this issue.

Beckman Coulter is advising users that if the bleach cycle is interrupted or aborted to ensure the daily shutdown and daily checks are performed prior to running any patient samples. Beckman Coulter will be performing a software update as a permanent correction. A review of previously generated results is at the discretion of the laboratory director.