Events

Etest Vancomycin / Teicoplamine X Polymyxin B, Registration No. 10158120623, lot: 1002338240 (Vancomycin / Teicoplamine) and lot 1002735070 (Polymyxin B). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BIOMÉRIEUX Brasil S.A.; BIOMERIEUX 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
    1438
  • 날짜
    2014-10-03
  • 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 manifestation of the company, this does not compromise the quality of the product offered, but may negatively influence the susceptibility to antibiotics (Vancomycin / Teicoplamine and Polimixin B), which could lead to an incorrect or late antibiotic therapy decision. doctor responsible.
  • 원인
    The company holding the registration identified that there was a misunderstanding in the nationalization labeling of etest vancomycin / teicoplamine and polymyxin b. the vancomycin / teicoplamine products were labeled with the nationalization label containing the product polymyxin b. the company informs that both the printed boxes of both products, as the internal identification of the strips is correct. the problem occurred only in item nationalization labeling, affixed externally to products.
  • 조치
    The company that holds the registration in Brazil informs that it has forwarded an explanatory letter to all the customers and distributors who acquired the affected lots, as detailed instructions on how to proceed with the products covered by this field action. The company advises customers and distributors to evaluate their inventory and if they have kits with the problem informed above, to interrupt these batches and return the Notification form to the Customer Service Department so that the recall can be scheduled.

Device

Etest Vancomycin / Teicoplamine X Polymyxin B, Registration No. 10158120623, lot: 1002338240 (Van...

Manufacturer

BIOMÉRIEUX Brasil S.A.; BIOMERIEUX S.A