| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00942-1 |
| Product Name/Description |
LIAISON Estradiol II Gen Assay (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD)
Part Number: 310680
All Lots affected
ARTG Number: 201366 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
DiaSorin is issuing a correction for the Liaison Estradiol II Gen Assay. Due to the risk of recently identified cross-reactivity, the Liaison Estradiol II Gen assay should not be used to test patients being treated with fulvestrant (Faslodex). Cross reactivity of the drug fulvestrant may lead to falsely elevated test results in estradiol assays. This is due to the fact that fulvestrant has a similar chemical structure to estradiol and may cross-react with antibodies used in immunoassays. Fulvestrant is indicated for the treatment of post-menopausal women with estrogen receptor positive recurrent stage IV breast cancer. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
DiaSorin is advising users to use an alternative method if measuring estradiol levels in patients being treated with fulvestrant, and advise clinicians that Fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug.
It is recommended laboratories consider the need to carry out a review of previously generated results.
DiaSorin will be updating the Instructions for Use (IFU) to contain additional warnings. This action has been closed-out on 22/02/2017. |
| Contact Information |
02 9338 4859 - DiaSorin Australia |