Events

DRY REACTIVES VITROS * FOR PHBR, Registration No. 10132590518, lot: 2538-0060-7597 and lot: 2540-0063-4175 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 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
    1247
  • 날짜
    2013-04-01
  • 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
    According to the company's statement, the manufacturer considers that it is a situation in which the use or exposure to the affected product may cause adverse or reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote. If in doubt, the company requests that you contact the Technical Services to the Customer at 0800-728-7865 or 11 9 8223. See Customer Letter at: http://portal.anvisa.gov.br/wps/ content / Anvisa + Portal / Anvisa / Reports + Tecnicos / Menu + - + Alerts + and + Reports / Alerts + de + Tecnovigilancia
  • 원인
    The manufacturer company has identified in research that positive bias values ​​for patient samples, which may have been obtained, could not be detected by quality control fluids.
  • 조치
    The company that registers in Brazil is collecting the product and advises that: i) Discontinue use and discard all VITROS PHBR Slides remaining in your inventory; ii) Complete and return the Receipt Confirmation form (attachment); iii) Send this notification to all laboratories in your facility that use VITROS PHBR Slides; iv) Place this notification next to each VITROS System using the VITROS PHBR Slides or together with your VITROS user documentation.

Device

DRY REACTIVES VITROS * FOR PHBR, Registration No. 10132590518, lot: 2538-0060-7597 and lot: 2540-...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda