ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2015-RN-01049-1

Class II

2015-10-28

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01049-1

Siemens healthcare diagnostics has identified multiple issues with the advia chemistry xpt systems with software version 1.0.3 that may affect the day to day behaviour and/or workflow of the system as follows:auto start-up failingcalibration interval resets when a reagent blank (rbl) is runcontrol definition screen assumes that the range is defined is 2 sd (standard deviation)laboratory information system (lis) communication / laboratory automation (las) issueprinter driver resetsise calibration ranges are too conservative for urine sodium (na)archiving and deletion may failworkstation services may restartwith the alerts generated by the instrument for the scenarios impacting samples, the operator will be aware that a sample may not have been processed and can take action. calibration and control issues are detectable through normal laboratory monitoring practices.

All the issues above except (Issue: Workstation services may restart) are corrected in software version 1.1 which is now available for installation on affected systems. The temporary actions defined in the customer letter should be undertaken until the affected systems have been upgraded to software version 1.1. The remaining issue will be corrected in a future software version.