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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00879-1
Product Name/Description	LIAISON Biotrin Parvovirus B19 IgM Part Number: 317010 Lot Number: 129022X, 129022X/1 Expiry Date: 12 December, 2014 ARTG Number: 203754 An in vitro diagnostic medical device (IVD)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	11/08/2014
Responsible Entity	DiaSorin Australia Pty Ltd
Reason/Issue	DiaSorin has become aware that the kit lots identified have a potential to produce an increased rate of positive results when used on LIAISON XL analyzer.
Recall Action	Recall for Product Correction
Recall Action Instructions	DiaSorin is recommending the retesting of all specimens resulting in an initial positive on the LIAISON XL analyzer unless, as part of the laboratory policy, these samples have already been confirmed by other method or by clinical evidence. The affected lots can still be used, but confirming all initially positive results with a different method or analyzer. DiaSorin is offering Parvovirus B19 IgM EIA, code V619IM free of charge to perform the retesting. This action has been closed-out on 03/06/2016.
Contact Information	1300 259 835 - DiaSorin Australia Pty Ltd