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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00331-1
Product Name/Description VIDAS 3 System (used with software version 1.1.4) An in vitro diagnostic medical device (IVD)

Catalogue Number: 412590

ARTG Number: 199422
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 14/03/2017
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue Software anomalies have been discovered in the VIDAS 3 software version 1.1.4. The following are the limitations that could impact the system:

1. The “error code 0550CAPU1” posted in case of tip lost does not suggest the appropriate troubleshooting
2. For customers using automatic pipetting mode: non-justified “error code 0400FAPU1”
3. Stop section during analytical phase can induce drop on the strip or into the instrument
4. For customers managing their internal/external quality control via Quality Control Module of VIDAS 3 only
5. For countries applying winter time change only
Recall Action Recall for Product Correction
Recall Action Instructions bioMérieux is advising users to apply the required actions associated with the relevant limitation (as described in the customer letter). Users are further advised to discuss concerns about previously reported results with their Laboratory Medical Director to determine the appropriate course of action.

This action has been closed out on 13/11/2018
Contact Information 1800 333 421 - bioMérieux Help Desk Department