| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01272-1 |
| Product Name/Description |
Xpert HIV-1 Viral Load Assay. An in vitro diagnostic medical device (IVD).
Catalogue Number: GXHIV-VL-CE-10
Lot Number: 1000034821 (Cartridge Lot: 14001)
Expiration Date : 09 October 2016
ARTG Number: 259967 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
Cepheid has received reports that some customers have experienced cartridge performance issues that manifest as abnormal PCR amplification curve patterns, which can yield invalid results (the most common outcome), or much less commonly, inaccurate quantification of HIV-1 RNA when using this test and its intended use specimen types. |
| Recall Action |
Recall |
| Recall Action Instructions |
Cepheid is advising users to stop using and dispose of any remaining product from the affected lot (Lot Number 1000034821). Replacement product will be provided. The results of previous tests performed with this lot of product should be discussed with the laboratory medical director to determine whether a look-back is required. If there are any concerns about the accuracy of the results contact Cepheid Technical Support who will analyse the GeneXpert data files (gxx files). This action has been closed-out on 10/05/2017. |
| Contact Information |
1800 107 884 - Cepheid |