UniCel DxH 600 & 800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2013-RN-01277-1

Class I

2013-11-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01277-1

Update: beckman coulter's investigation has shown that the dxh cleaner were the main contributor to the optical degradation issue.Complaints related to optical degradation have increased on the dxh 800 and dxh 600 systems. customers have reported that they are experiencing an increase in one or more of the following:- flow cell clogs (::::)- ls offset errors during daily check or control analysis- high coefficients of variation (cv) for latron cp-x controls for low angle light scatter (lals) and/or axial light loss (all) parameters- system messages and r-flagged results for nrbc, diff and retic during control or patient analysis, such as partial clogs (low event rated with diff rs) or a voltage failure (system event: d with diff rs)the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells, white blood cell differential and/or reticulocytes.

Update: Beckman Coulter is requesting their customers to discard the affected lot of DxH Cleaner. Laboratories can discontinue the additional flush flow cell and cleaning actions. Beckman Coulter is recommending users perform a Flush Flow Cell, Extended Cleaning and perform a routine shutdown at least daily. A permanent fix will be implemented when available.