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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00143-1
Product Name/Description ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. An in vitro diagnostic medical device (IVD)

Adenovirus R-gene Quantification Standard (QS) and Sensitivity Control (SC)
Refernece Number: 69-010B
Lot Number: 1005056960
Expiry date: 25/08/2018

Parechovirus R-gene Postive control (PC20)
Reference Number: 71-020
Lot Number: 1005090480
Expiry Date: 31/08/2018

ARTG Number: 211361
(Biomerieux Australia - Viral infectious disease IVDs)
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 20/02/2018
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue It has been identified that a proportion of kits in the ARGENE range have been mislabelled, where the target name is missing from the tube label. The kits are colour coded by reference to minimise the risk of mixing tubes from different references.
Recall Action Product Defect Alert
Recall Action Instructions BioMerieux is advising users that the affected product can continue to be used. Users are reminded that the affected products are colour coded by reference, and include the reference number on the labelling.

This action has been closed out on 12/02/2019
Contact Information 1800 333 421 - Customer Service Support