| 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 |
|
| 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 |