Events

ARCHITECT TESTOSTERONE - Records 80146501466, 80146501467, 80146501468. Affected Lots - 11907JN01, 13909JN01, 15909JN01, 15916JN00, 1897JN01, 18907JN02, 201901JN01, 11907JN00, 13909JN00, 15909JN00, 15916JN01, 18907JN00, 21901JN03, 21901JN04, 17342JN00, 19142JN00, 19142JN01, 19142JN02, 22270JN00 , 23277JN00, 23277JN01, 17203JN00, 19075JN00, 22121JN00 and 23199JN00. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATÓRIOS DO BRASIL 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
    1222
  • 날짜
    2013-01-15
  • 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
    Exposure to materials containing Methylisothiazolones may cause an allergic skin reaction. Personal protective equipment should be used in accordance with your laboratory practice to ensure adequate protection against such an event. This warning is not a result of any adverse events reported in relation to the product marketed. Anvisa follows this Field Action. #### UPDATE - 04/29/2013 - CLOSURE of the action communicated by the company.
  • 원인
    The current architect testosterone reagents, calibrators and controls labels do not contain warnings and precautions applicable to materials containing methyl-isotiazolones, classified as skin sensitizers.
  • 조치
    The company recommends to professionals users: 1) Treat this product as skin sensitizer. 2) If you have forwarded the products listed in the List of Affected Lots list distributed in Brazil to other laboratories, please provide a copy of this notice to the laboratory in question. 3) Keep a copy of this notice for future reference. 4) The instructions for use shall be corrected from the following lots: ARCHITECT Reagents Testosterone, from lot 24900UI01 - Reagents ARCHITECT Testosterone, from lot 24900UI00 - ARCHITECT Testosterone Calibrators, from lot 24912UI00 - Controls ARCHITECT Testosterone, from from lot 24911UI00

Device

ARCHITECT TESTOSTERONE - Records 80146501466, 80146501467, 80146501468. Affected Lots - 11907JN01...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA