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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 Biomerieux Australia Pty Ltd
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