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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00014-2
Product Name/Description	ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD) Part Number: 10-9475-01 Lot Numbers: All lot numbers when used in combination with ImmunoCAP Allergen i1 Honey bee venom art. No 14-4143-01, lot numbers 389B7 and 389B8 ARTG Number: 186054
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	15/01/2016
Responsible Entity	Abacus ALS Pty Ltd
Reason/Issue	The ranges for mean concentration of IgG/IgG4 stated on the vial label of the quality control sample are incorrect. The new measuring ranges for ImmunoCAP Specific IgG/IgG4 i1 Control H, all lots when used in combination with ImmunoCAP i1, lot 389B7 and 389B8 are: IgG4: 12 – 25 mg/l IgG: 24 - 47 mg/l The problem can be detected by the operator since the quality control samples will fail.
Recall Action	Recall for Product Correction
Recall Action Instructions	The sponsor is advising users to use the following new measuring ranges for ImmunoCAP Specific IgG/IgG4 i1 Control H: IgG4: 12 – 25 mg/l IgG: 24 - 47 mg/l Patient results are not affected. No action needs to be taken in regards to past or current patient results for ImmunoCAP Allergen i1, Honey bee venom.
Contact Information	1800 222 287 - Abacus ALS