VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Control VIDAS (QCV) 의 리콜

Recall

RC-2018-RN-00060-1

Class II

2018-02-13

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00060-1

A review of relevant data and feedback from users has identified there are some pump clogging and displacement of the colour coded label. the pump clogging could contribute to erroneous results for any assay performed on the vidas and mini vidas system due to decrease of pipetted volume.

bioMérieux is advising users to implement the following permanent changes in managing the affected systems: 1. Increase the frequency of the QCV testing to weekly rather than monthly to reduce the period of potential retrospective analyses needed. In the event of QCV test fail, it is recommended to review previous results with the laboratory medical director, and perform a retrospective analysis of all patient specimens processed since the last successful QCV test. bioMérieux will update the User Manual to reflect this requirement 2. As indicated within the Instructions For Use, continue to conduct a visual inspection of the SPR after each run (including patient sample test and QCV test) to ensure that the dot on the SPR is still in place In response, bioMérieux is taking action to help ensure the instruments perform as intended: 1. Pumps have to be changed every 7 years 2. bioMérieux will systematically clean the VIDAS/mini VIDAS pumps during the yearly Preventive Maintenance