| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00159-1 |
| Product Name/Description |
VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic medical device (IVD)
Reference Number: 30202
Multiple Lot Numbers affected
ARTG Number: 209618 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Following a complaint from a customer related to discrepant results observed when testing heat inactivated sera, bioMérieux performed an investigation concluding that the performance of VIDAS TOXO IgM kit while using with heat inactivated sera (56°C for 30 minutes) is not in accordance with the performance characteristics as stated in the IFU.
The investigation confirmed that the index results obtained with inactivated sera are lower compared to values obtained with fresh sera and may result in false negative results. In remote cases this may result in a delayed diagnosis and treatment for immunocompromised patients, organ transplanted patients, foetuses (in the case of gestational infection) and neonates. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Biomerieux is advising users to not use heat inactivate sera before testing.
Any concerns regarding previously generated results should be discussed with the Laboratory Director.
This action has been closed out on 25/10/2018 |
| Contact Information |
1800 333 421 - bioMerieux Help Desk Department |