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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00778-3
Product Name/Description ARCHITECT Toxo IgG; An in vitro diagnostic medical device (IVD)

List Number: 6C19-25

Lot Numbers: 15070LI00
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/08/2012
Responsible Entity Abbott Australasia Pty Ltd Diagnostic Division
Reason/Issue ARCHITECT Toxo IgG reagent lots 15070LI00 (List number 6C19-25) are showing reduced specificity which may cause a shift to higher IU/mL values leading to increased grayzone and/or reactive results. The assay sensitivity is not impacted and current data indicated that no other lots are affected.
Recall Action Recall
Recall Action Instructions Quarantine and discard affected products. Abbott recommends discussing previous results with Laboratory Management and healthcare providers to determine if any further testing is required.
Contact Information 1800 816 696 - Abbott Customer Support