| 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 |
|
| 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 |