| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00012-1 |
| Product Name/Description |
Xpert HIV-l Viral Load. An in vitro diagnostic medical device (IVD)
Catalogue number - GXHIV-VL-CE-10
ARTG Number 259967 (Cepheid Holdings Pty Ltd - Human immunodeficiency virus (HIV) IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Since beginning of 2017, three incidents of discrepant results were reported to the European Competent Authorities involving the Xpert HIV-l Viral Load test and other alternative methods where the Xpert HIV-1 Viral Load assay did not detect the variant of HIV. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Cepheid recommends that each user of the Xpert HIV-l Viral Load test is informed about the update of the package insert which is now including the following additional limitation: “Rare mutations within the target region of the HIV-1 VL assay may affect primer and/or probe binding resulting in under-quantitation of virus.”
This action has been closed out on 17/10/2018 |
| Contact Information |
1800 107 884 - Customer Support Centre |