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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00060-1
Product Name/Description VIDAS and mini VIDAS systems. An in vitro diagnostic medical device (IVD)

In combination with Quality Control VIDAS (QCV) (ARTG: 203664)

Multiple Reference Numbers

ARTG Number: 199422
(Biomerieux Australia Pty Ltd - Instrument/analyser IVDs)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/02/2018
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue 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.
Recall Action Product Defect Correction
Recall Action Instructions 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

This action has been closed out on 12/07/2019
Contact Information 1800 333 421 - bioMérieux Technical Support