Events

Product name: Estradiol Life II Technical Name: Estradiol Life II ANVISA Registration Number: 10158120172 Hazard Class: I Affected Model: Affected serial numbers: Lot: 1004403350, 1004343690, 1004490710, 1004661480, 1004666000. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 bioMérieux Brasil S.A.; bioMérieux S.A 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
    2172
  • 날짜
    2016-08-12
  • 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
    1- Sending a letter to the usual customers / distributors of the product (Annex to this Notice) with the guidelines necessary to use the product. 2- See the step-by-step action plan that will be developed to notify all customers until the manufacturer includes in the instructions for use the risk of cross-reaction of the Vidas Estradiol II kit with the drug Fulvestrant.
  • 원인
    Biomérieux sa france manufacturer of the product vidas estradiol ii, was contacted by the national agency for the safety of medicines and products for health of france - ansm; to verify the occurrence of cross-reaction of the kit in question, or other kits for dosing estradiol, with the product fulvestrant. this request came from the fact that ansm was informed of this occurrence with a siemens healthcare company product. based on ansm's report, biomérieux sa opened an internal investigation (pr965756) and a study was carried out with the vidas family of equipment (vidas, mini-vidas and vidas3) together with the vidas estradiol ii kit, the only test for estradiol by biomérieux sa the investigation concluded that fulvestrant is cross-reactive with the vidas test. the cross-reactivity study done according to the principles of the clsi guide ep7-a2 "interference test in clinical chemistry" guide approved second edition, demonstrated that the cross-reactivity percentage obtained for fulvestrant is a maximum of 0.32% for a drug concentration of 20,000pg / ml.
  • 조치
    Field Action Code FSCA 3039 triggered under the responsibility of the company bioMérieux Brasil SA Company will inform the clients.

Device

Product name: Estradiol Life II Technical Name: Estradiol Life II ANVISA Registration Number: 101...

Manufacturer

bioMérieux Brasil S.A.; bioMérieux S.A