| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00482-1 |
| Product Name/Description |
Elecsys Estradiol Assay with Fulvestrant. An in-vitro diagnostic medical device (IVD)
Product affected: Estradiol III
Material Number: 06656021190
All lots affected
ARTG Number: 174907
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diagnostics has tested for fulvestrant interference / cross-reactivity with the Elecsys Estradiol assay; this investigation has shown that fulvestrant could potentially affect patient sample results.
The reported issue may lead to falsely elevated results of Estradiol. Subsequently, misinterpretation of the hormone status could occur and the use of fulvestrant may be altered. In addition, the efficiency of anti-estrogen treatment might be underestimated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is advising customers that Fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. A review of estradiol assay results in patients taking fulvestrant is recommended. A disclaimer will be added to the “Interference – Limitations” section in the Method Sheet of the Elecsys Estradiol III assay: This action has been closed-out on 30/01/2017.
“Due to the risk of cross reactivity, this assay should not be used when monitoring estradiol levels in patients being treated with Fulvestrant.” |
| Contact Information |
02 9860 2313 - Roche Diagnostics Australia |