Print version of this report
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