Events

Safety Alert for Commercial Name: VITROS ECI FOR IMMUNODIAGNOSTIC REAGENT KIT FOR ESTRADIOL //. Technical Name: 30321 Estradiol // Registration 10132590405 - Risk Class II (Medium Risk) // Product code 8552630 // Lots affected and imported in Brazil: 1470, 1480, 1490, 1500, 1510, 1528, 1538, 1548, 1558 , 1568.//

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1981
  • Date
    2016-08-17
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    The company informs that: • Before receiving the revised Instructions for Use (IFU), be aware that positive deviation results may occur for patients taking Fulvestrant. Follow your normal laboratory procedures, as you would for other known sample interferences. Note: It is acceptable to continue using VITROS Reagent Kits for Estradiol. • Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action. • Place this notification on your VITROS System or along with your user documentation.
  • Reason
    Ortho clinical diagnostics (ortho) has been aware of the potential for drugs, which are derived from estrogen (eg fulvestrant, trade name: faslodex®), in interfering with estradiol immunoassays and causing positive deviation results. because of this problem, we are initiating this urgent product fix.
  • Action
    1. Type of Field Action: Updating, correcting or supplementing the instructions for use. 2. Field Action Code: 16000112 3. Recommendations to Users and Patients: According to the company, Ortho's research confirmed results of Estradiol with positive deviation in samples obtained from postmenopausal women containing 30 ng / mL of Fulvestrant (peak serum concentration of this therapeutic drug). Events that may have occurred prior to this communication are not easy to identify without knowledge of Fulvestrant administration for each patient; thus a review of past results may not be possible. Consider the need to notify your physicians / clinicians about oestradiol results for women who have received Fulvestrant. Talk to your Lab Medical Director about any questions you may have regarding previously reported results for estradiol to determine the appropriate course of action. The results of this or other diagnostic test should be used and interpreted only within the context of the general clinical picture.

Device

Commercial Name: VITROS ECI FOR IMMUNODIAGNOSTIC REAGENT KIT FOR ESTRADIOL //. Technical Name: 30...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics