AQUIOS CL Flow Cytometry System, software versions 2.0, 2.0.1, 2.1. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-01489-1

Class II

2017-12-06

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01489-1

Beckman coulter has noted an issue with duplicate sample requests when using the aquios cl systems connected to a laboratory information system (lis).1. host query errora) when aquios cl systems are connected to a laboratory information system (lis) directly or through middleware, the system may duplicate sample requests leading to sample mis-identification. 2. cassette unloading duplicationa) all aquios cl systems may duplicate sample requests if a cassette is not properly unloaded by the instrument. these sample duplications do not result in mis-identification. b) sample id duplication caused by errors with cassette unloading will present as non-sequential duplications. on the review and results screen, one or more sample ids from same instrument (serial number) will be listed with a run time between duplicate sample id entries. both issues described above are present in all software versions (2.0, 2.0.1 and 2.1) and all applications used on aquios cl are impacted.

Beckman Coulter is working on a software upgrade to permanently correct and eliminate these issues. In the interim, Beckman Coulter is advising users who are experiencing the identified issues to follow the instructions provided on the Customer Letter until the software upgrade has been released and installed. Beckman Coulter will be in contact with users to assist in determining whether previous samples run in laboratories were impacted by host query misidentifications. A retrospective review of results obtained is at the discretion of the Laboratory Manager.