Events

Alerte De Sécurité sur 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.//

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1981
  • Date
    2016-08-17
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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