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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00978-1
Product Name/Description	ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro diagnostic medical device (IVD) Kit Article Number: 10-9530-01 Kit Lot Numbers: JBWA, JEXG Vial Lot Number: CYYAC ARTG Number: 186054
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/07/2016
Responsible Entity	Abacus ALS Pty Ltd
Reason/Issue	Abacus are informing users regarding an issue regarding ImmunoCAP Specific IgE Control H vial lot CYYAC. Precipitates have been identified in the affected vials and kit lots. If samples containing precipitates are used, an increased frequency of functional disturbances (error messages e.g. clot error etc.) is to be expected in the instruments. Occurrence of precipitate in the control, such as in vial lot CYYAC, could give an increased frequency of functional disturbances in the instruments. However, in-house studies undertaken by the manufacturer show no indication that the IgE results would be affected by the precipitates.
Recall Action	Recall
Recall Action Instructions	Abacus is advising users to inspect stock and discard any remaining kits of the affected lots. Affected product will be replaced by unaffected lots. This action has been closed out on 13 Jun 2017
Contact Information	1800 222 287 - Abacus ALS