Dimension Vista 500 and 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-00430-1

Class II

2015-05-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00430-1

Issue 1: samples may stop processing without notification on the dimension vista 500 or dimension vista 1500. this issue is due to a failure to exchange aliquot plates, causing the lane to become unavailable. issue 2:complaints were received on the dimension vista 1500 for a series of unexpected results, some of which were not flagged with errors or results that were flagged with errors. it has been determined that under a rare set of conditions, a timing issue may cause a reagent server to temporarily lose synchronisation during the automatic removal of reagent cartridges from reagent server 2 to waste a container. in the extremely unlikely circumstance that this issue occurs, a flag will be generated for the majority of assays. however, there is the potential to produce unflagged erroneous but believable results for some assays.

Users are provided with temporary workarounds in the customer letter. Siemens will be providing corrections for the issues in a future Vista software version. Review of previously generated results due to this issue is at the discretion of laboratory. This action has been closed-out on 26/08/2016.