Events

LIVES HBsAg ULTRA. Registered N °: 10158120583. Lot Affected: 820592901. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biomerieux Brasil 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
    937
  • 날짜
    2008-08-02
  • 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
    Inside the kit are two silver packs containing the cones. In this case, some of the VIDAS HBsAg Ultra product packs were filled with VIDA CK-MB kit cones and labeled as VIDAS HBsAg Ultra.
  • 원인
    Some product units belonging to lot 820592901 were filled with material from a different diagnostic kit (vidas ck-mb) and labeled as vidas hbsag ultra.
  • 조치
    Biomérieux Brasil SA has already started, through communication letters, the contact with the clients involved. The collection of affected products in Brazil has also been started by the company. The recommendations to the users are as follows: (1) for all the tests carried out with the product (of the lot under risk) and that presented NEGATIVE result, to contact the patients and to arrange a new test; (2) Immediately verify in stock the existence of lot no. 820592901 of the product; (3) If products of the batch in stock are located, segregate the products at risk and identify them immediately in order to avoid their use; (4) Contact the company through the Product Pickup Notification Letter; (5) Confirm, prior to the laboratory analysis and regardless of the batch number, whether the color of the BARRETE is the same as that of the CONE.

Device

LIVES HBsAg ULTRA. Registered N °: 10158120583. Lot Affected: 820592901.

Manufacturer

Biomerieux Brasil S.A.