ADVIA Chemistry XPT System with software versions 1.0.3 and 1.1. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00569-1

Class II

2016-05-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00569-1

Siemens has identified multiple software issues that may affect the day-to-day behaviour and/or workflow of the system.1. all levels of qc run when only 1 is selected in start/restart window 2. changing the display name of an assay deselects that method in its associated qc panel, therefore qc for the renamed assay will not run as part of the panel. 3. a workstation services restart screen may appear under multiple scenarios, causing the user interface to be temporarily inaccessible. the user will be prompted to login once the services restart. a.Workstation services may restart if a user defined filter is created in the test results overview screen that includes the 31st day of the month, but is run in a month that does not have 31 days. b.Workstation services may also restart when all items are removed from the watchlist. 4. the chemistry xpt software does not update assay utilisation counters for ise tests when patient samples and qc samples are run in version v1.1.

Siemens is providing users with work around instructions to follow as an interim measure. A software upgrade will be installed as a permanent correction. Users are advised to review the issues with the Medical Director.