Events

Cholesterol FS - Registration 10350840010; Creatinine PAP FS - Registration 10350840205; Glucose GOD FS (Glucose GOD FS) - Registration 10350840018; HDL-C Immuno FS - Registration 10350840066; LDL-C Select - registration 10350840085; NEFA FS - Registration 10350840251; Triglycerides FS - Registration 10350840011; Uric Acid (TBHBA) FS (Uric acid FS) - Registration 10350840020; Uric acid FS TOOS - Registration 10350840199 - LOTS - All lots 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biosys Ltda; DiaSys Diagnostic Systems Gmbh 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
    1666
  • 날짜
    2015-08-20
  • 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 interference of the drugs N-acetylcysteine ​​(NAC), acetaminophen (acetaminophen) and metamizole (dipyrone) is related to the occurrence of falsely low test results using the Trinder reaction, when sample collection to perform the tests is performed immediately after the administration of the same.
  • 원인
    Biosys ltda., the holder of the registrations of the above mentioned products, received a communiqué from the international manufacturer, diasys diagnostic systems gmbh, informing that the products that use as a methodology the reactions called trinder, suffer interference due to the following drugs: n-acetylcysteine ​​(nac), acetaminophen (acetaminophen) and metamizole (dipyrone) given in therapeutic doses. trinder's reactions are based on a color reaction in which the hydrogen peroxide (h2o2) is formed and subsequently reacted with amino-antipyrine (a phenol derivative) and peroxidase as the catalyst. peroxidase reactions have been observed to undergo interference to varying degrees by the drugs mentioned. the products cited use the trinder reaction as a methodology. biosys informs that it has not been notified until the moment of occurrence related to this interference in national territory.
  • 조치
    The company recommends blood collection before administration of the following drugs: N-acetylcysteine ​​(NAC), acetaminophen (paraceamol) and metamizole (dipyrone), when testing for the following analytes: Cholesterol, Glucose, HDL, Triglycerides and Uric Acid, which use in their methodology Trinder reactions (products and numbers of registries listed - Annex I). The company made the information available on its website. Further information check: Annex II - Notice to the Client and Annex III - Distribution Map

Device

Cholesterol FS - Registration 10350840010; Creatinine PAP FS - Registration 10350840205; Glucose ...

Manufacturer

Biosys Ltda; DiaSys Diagnostic Systems Gmbh
  • Source
    ANVSANVISA