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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00599-1
Product Name/Description	EliA IgG Conjugate. An in vitro diagnostic medical device (IVD). EliA IgG Conjugate 50 Article Number: 83-1017-01 EliA IgG Conjugate 200 Article Number: 83-1018-01 EliA IgG Conjugate Article Number: 83-1005-01 EliA IgG Conjugate Article Number: 83-1002-01 Multiple Lots and Kits affected ARTG Number: 229585
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	27/05/2016
Responsible Entity	Abacus ALS Pty Ltd
Reason/Issue	Investigation of complaints received has concluded that when using EliA CCP Well (14-5515-01) in combination with EliA IgG Conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01), anti-CCP-signals can be elevated for the listed conjugate lots. The positive bias of the EliA CCP test will change a small percentage of test results from negative to equivocal and equivocal or high negative to low positive. Testing on clinical samples of both confirmed Rheumatoid Arthritis (RA) patient sera, healthy blood donors and other disease controls resulted in < 1% of the samples changing from negative to positive, according to current cut-off ranges (total study includes 472 samples). The results of the assay evaluation studies performed confirm the variance to be within current clinical performance, and it is concluded that the clinical impact of the observed bias is negligible.
Recall Action	Recall
Recall Action Instructions	The sponsor is advising customers to stop using EliA CCP Well (14-5515-01) in combination with EliA IgG Conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01) of the affected lots as stated. The sponsor will provide unaffected EliA IgG conjugate lots as soon as they become available. This action has been closed-out on 15/02/2017.
Contact Information	1800 222 287 - Abacus ALS