Events

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.// 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1981
  • 날짜
    2016-08-17
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    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.
  • 조치
    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