Methotrexate Assay performed on Syva Emit Methotrexate Application (DVMTX.1) for the Dimension Vista System. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-00332-1

Class II

2016-03-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00332-1

Siemens has identified that the syva emit methotrexate application for the dimension vista system does not meet the on-board stability claim of 20 hours. internal testing using reagent at the end of the 20 hour on-board stability has shown that values of methotrexate for patient and quality control samples increased.The observed bias for patient and qc samples measured within the first 4 hours of the on-board stability was < 10%. if users have run methotrexate patient samples and qc in batch, qc can detect the issue. the risk to health as a result of this issue is limited to patient samples that are not run with quality control once reagents have been on-board the instrument for >4 hours. when this issue occurs, the potential exists to report falsely elevated methotrexate concentrations and to consider adjustment of folinic acid administration.

Siemens is recommending that laboratories retest methotrexate samples that were run within the previous 24 hours where the following criteria are met: (1) Samples were run without Quality Control >4 hours after reagent was loaded on the instrument, and (2) Samples are within the specified storage conditions and time. Siemens is withdrawing the Emit Methotrexate Application on the Vista system and can advise users of alternative testing methods for methotrexate. Siemens is recommending users change the On-board stability for the methotrexate application to four hours, or run in batch mode with QC. This action has been closed-out on 16/05/2017.