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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00954-1
Product Name/Description Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD)

Catalogue Numbers: 72386 and 72388

Multiple lot numbers

ARTG Number: 134410
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/09/2012
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue As a TGA condition for product registration, the Genscreen HIV Ag/Ab Ultra was accepted for 9 months shelf life not 12 months as stated on the packaging. The Genscreen HIV Ag/Ab Ultra kit was distributed to customers after May 2011 without the warning label: "Customers are advised to subtract 3 months from the expiry date to obtain the new expiry date of the kit".
Recall Action Recall for Product Correction
Recall Action Instructions Customers are being advised that for lots within the TGA accepted shelf life investigation of result validity should be carried out as per the package insert and for lots used outside of the accepted shelf life retesting of patient samples should be considered at the discretion of the laboratories Clinical Laboratory Director.
Contact Information 1800 224 354 - BioRad Laboratories