Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical chemistry analyser. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2013-RN-00649-1

Class II

2013-06-28

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00649-1

Siemens healthcare has confirmed that, under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a qc or calibrator product from a vista vial. if two samples are dispensed into the same aliquot well, the first sample will always be qc or calibrator from a vista vial. patient sample will never be dispensed into an aliquot well that contains another patient sample.

In the event of an instrument reset, end users are requested to check if there are any QC or calibration tests pending. If there are QC or calibrations pending a software restart is necessary before resuming patient processing. If there is no QC or calibration pending reset or troubleshoot the instrument as per the Operators Guide. A software update will be provided as a permanent fix.