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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01496-1
Product Name/Description	ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. An in vitro diagnostic medical device (IVD). ImmunoCAP Specific IgG/IgG4 i1 Control H Article Number: 10-9475-01 Vial Lots: with expiry date up to July 2017 (C6XAX or older) ImmunoCAP Allergen i1, Honey bee venom Article Number: 10-4143-01 Lot Numbers: 389B7, 389B8, 389B9, 389BA & 389BB ARTG Number: 186054
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	21/11/2016
Responsible Entity	Abacus ALS Pty Ltd
Reason/Issue	For particular lot combinations of ImmunoCAP specific IgG/IgG4 i1 Control H and ImmunoCAP Allergen i1, Honey bee venom, the ranges for mean concentrations of IgG and IgG4 stated on the vial label of the quality control sample are incorrect. The problem can be detected by the operator as the quality control samples will fail. The issue affects the ImmunoCAP Specific IgG/IgG4 i1 Control H samples only; patient results for i1 are not affected by the lot number of ImmunoCAP Allergen i1, Honey bee venom, used to generate the assay result. The correct measuring ranges for the quality control are being provided.
Recall Action	Recall for Product Correction
Recall Action Instructions	Abacus ALS is providing users with the correct measuring ranges for ImmunoCAP Specific IgG/IgG4 i1 Control H, vial lots with expiry date until July 2017 (C6XAX or older), when used in combination with ImmunoCAP i1, lots 389B7, 389B8, 389B9, 389BA & 389BB. The correct ranges are: IgG4: 12 – 25 mg/l and IgG: 24 - 47 mg/l. No action needs to be taken in regards to past or current patient results for ImmunoCAP Allergen i1, Honey bee venom. This action has been closed out on 15 June 2017.
Contact Information	1800 222 287 - Abacus ALS