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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00013-2
Product Name/Description	EliA SmDP Well Part Number: 14-562-01 Lot Numbers: 0018 and 0019 Expiry Dates 30 November 2016 and 31 March 2017 ARTG Number: 229585
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/01/2016
Responsible Entity	Abacus ALS Pty Ltd
Reason/Issue	There have been unusually high numbers of positive results with EliA SmDP well lots, which are not due to anti-Sm antibodies. All equivocal and positive patient sample results measured with lots 0018 and 0019 are potentially incorrect and are thus considered to be invalid. A false positive result could lead to unnecessary treatment/procedures. There is no indication that negative results generated with EliA SmDP well lots 0018 and 0019 are affected.
Recall Action	Recall
Recall Action Instructions	This action has been closed out 08 Jun 2017.
Contact Information	1800 222 287