| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00982-1 |
| Product Name/Description |
VITROS Immunodiagnostic Products Estradiol Reagent Pack (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD)
Product Code: 8552630
Lot Numbers: 1470, 1480, 1490, 1500, 1510, 1528, 1538, 1548, 1558, 1568
ARTG Number: 176641 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics (Ortho) was made aware of the potential for medications that are derivatives of estrogen (e.g. Fulvestrant) to interfere with Estradiol immunoassays and cause positively biased sample results. Ortho’s investigation confirmed positively biased Estradiol results on samples obtained from postmenopausal females containing 30 ng/mL of Fulvestrant (peak serum concentration of this therapeutic drug). Fulvestrant is an estrogen receptor antagonist medication that blocks estrogen from tumors. Due to the risk of the recently identified cross reactivity, Estradiol assays should not be used to test patients being treated with Fulvestrant. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho is advising users to use an alternative method for testing estradiol levels in patients being treated with fulvestrant. Users should be aware of the possibility of positively biased results. Consider the need to notify clinicians regarding estradiol results for women who are administered Fulvestrant. Customers are advised to discuss any concerns regarding previously reported results with you laboratory Medical Director.
Ortho will be issuing revised Instructions for Use (IFU) to include additional information in the 'Limitation of Procedure' section. This action has been closed-out on 02/05/2017. |
| Contact Information |
1800 032 359 - Ortho Customer Technical Services |