Events

VITEK 2 AST-YS 07. ANVISA Registration No. 10158120592. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biomerieux Inc. 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
    1552
  • 날짜
    2015-04-22
  • 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 risk assessment carried out by the company, the SEVERITY of the potential consequences for patients of incorrect or delayed results may be considered CRITICAL, which may lead to permanent deterioration, high impact on the patient's health or even death . The probability of occurrence was determined by the company as OCASIONAL, which means "possible to occur a few times during the product life cycle." The general risk posed by the company is MODERATED in a general way. relevant in Brazil since Flucitosycin is not used as therapy in case of fungemia (as it appears in the technical literature available in the market).
  • 원인
    During the quality control tests to be performed by the clients, it was identified that strain atcc 6258 - candida krusei, naturally resistant to the antibiotic flucitosina, presented results outside the minimum range required for such antibiotic, which means a sensitive result for flucitosina.
  • 조치
    The company has already started communicating with its customers, alerting to the problem in question and is developing a new formulation for the product, which should be available within 6 months. Identify if you have products at risk in stock and carefully read the letter disclosed by the company, to take the necessary steps - letter available at http://portal.anvisa.gov.br/wps/wcm/connect/bae52680481c317688dfadbdc15bfe28/Notifica%C3 A + A + + + + + + + + + + + + + + + + + + + + + + + A9rieux.pdf • MOD = AJPERES)

Device

VITEK 2 AST-YS 07. ANVISA Registration No. 10158120592.

Manufacturer

Biomerieux Inc.