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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01240-1
Product Name/Description	LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD). Part number: 310880 Lot Number: 089054X , 089054X/1 and 089054X/2 Expiry date January 9th, 2016 for all three lots ARTG number: 208811
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	21/11/2014
Responsible Entity	DiaSorin Australia Pty Ltd
Reason/Issue	DiaSorin has become aware that the kit lots identified have a potential to produce invalid calibrations due to either a Calibrator 1 Deviation percentage [%] outside the high limit, or due to the GCC (Geometrical Curve Check) out of range. As a consequence the calibration cannot be validated and the testing with these lots on the analyser cannot be performed.
Recall Action	Recall
Recall Action Instructions	Diasorin is recommending that use of the affected lot be ceased and any units be discarded. Results obtained with a valid calibration are considered to be reliable; therefore, review of past patient results is not deemed necessary, but at the discretion of the laboratory director. This action has been closed-out on 01/03/2016.
Contact Information	1300 259 835 - SiaSorin Australia Pty Ltd