AQUIOS CL Flow Cytometer utilising software versions 2.0 and 2.0.1. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00476-1

Class II

2017-04-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00476-1

Beckman coulter has confirmed that the export feature located in the results area of the aquios system software is not correctly exporting tetra combo crd files. upon import of the exported file to another aquios workstation, two individual files will be generated in the results tab rather than one combo file. the data and results on the acquisition system are not impacted. the possibility for erroneous results will occur under the following sequence of events:- using the export button to export a tetra combo crd file from the acquisition system; and- importing the data into a different system with a highly populated database; and - moving a region in any of the plots will generate erroneous results upon recalculation of the data.

Beckman Coulter will be addressing the issue in a subsequent software release. In the interim, Beckman Coulter is advising users to not use the Export button located in the Results area to export Tetra Combo CRD files and to export the files using the export icon, which exports the run displayed on the screen. For further instructions, users should refer to the AQUIOS Instructions for use, PN B21896 AD, Chapter 6- Data Review.