Events

Recall of VITROS Immunodiagnostic Products Estradiol Reagent Pack (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ortho-Clinical Diagnostics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00982-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00982-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

VITROS Immunodiagnostic Products Estradiol Reagent Pack (used for the determination of estradiol ...
  • Model / Serial
    VITROS Immunodiagnostic Products Estradiol Reagent Pack (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD)Product Code: 8552630Lot Numbers: 1470, 1480, 1490, 1500, 1510, 1528, 1538, 1548, 1558, 1568ARTG Number: 176641
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics