| 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 |
|
| 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 |