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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00992-1
Product Name/Description	ARCHITECT HAVAb-IgG Assay (Indicated as an aid in the diagnosis of hepatitis A viral infection or detection of IgG anti-HAV ). An in-vitro diagnostic medical device List Numbers: 6C29-20 and 6C29-25 Multiple Lot Numbers
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	26/09/2012
Responsible Entity	Abbott Australasia Pty Ltd Diagnostic Division
Reason/Issue	The ARCHITECT HAVAb-IgG assay shows a shift in the serum and plasma results to higher S/CO values over time, potentially leading to reduced specificity and increased false reactive results. The expiration dates for all affected reagent lots are being revised.
Recall Action	Recall for Product Correction
Recall Action Instructions	Abbott is providing work around instructions for users to implement until permanent preventive measures are implemented.
Contact Information	1800 816 696 - Abbott Customer Support