V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00533-1

Class II

2017-05-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00533-1

Siemens healthcare diagnostics has confirmed two issues related to the v-lyte integrated multisensor technology (imt) system. the issues regarding the v-lyte dilution check solution and the v-lyte imt system are:1. dilution check relative bias failures - a high rate of dilution check relative bias failures of greater than 2% when using specific lots of v-lyte dilution check solution; and2. integrated multisensor (imt) urine sodium drift - elevated urine sodium quality control (qc) exceeding acceptable qc ranges with the dimension vista imt system. a greater urine sodium drift with urine qc than urine patient samples has been observed. however, not all imt sensors exhibit the described urine sodium qc drift.

1) For repeated dilution check relative bias failures, Siemens is advising users to contact Customer Care Centre for further assistance. 2) For repeated elevated urine sodium QC drifts, users are advised to load a new Integrated Multisensor Technology (IMT) sensor in addition to coordinating a combination of the steps detailed in the recall letter to minimise or eliminate the drift of urine sodium QC and patient samples as well as to prevent premature sensor replacement and additional troubleshooting. Users are requested to review the letter with their Medical Director.