Events

Trade Name: HDL DIRECT - PP 400 /// registration: 80022230071. /// Model //// Lot: 5003; 5004 and 6001 // risk class II 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Gold Analisa Diagnóstica 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
    1934
  • 날짜
    2016-06-30
  • 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
    Recommendations to users and patients: Adopt the new values ​​of the controls for the analyte. Disregard the values ​​previously reported through the tables included in the kits.
  • 원인
    The supplier informed gold analisa, through the statement, that the values ​​of control and p soros (lot: 4001) for the hdl direct product (cat.400) would be changed exclusively for lot 5003 of this product. for lot 5003 of hdl direct-pp product (cat.400) gold analisa provided an alert message and inserted into all kits of the batch in question. from the lots 5004 and 6001, sac, from gold analisa began to register several customer calls regarding the performance of the product. it was then that they found that the values ​​passed by the supplier for the control sera p and n were inverted. in addition to the inversion of the values ​​the supplier has committed another failure. the new values ​​for the control sera n and p would be maintained from lot 5003, not "exclusively" for lot 5003 as previously reported. if you use these controls as a tool for calibration validation, there is a high risk of releasing erroneous results. it is worth mentioning that the purpose of the control sera is for the laboratory to monitor the analytical inaccuracy of its measurements.
  • 조치
    Action code RNC 13/2016. Recommendations to users and patients: Adopt the new values ​​of the controls for the analyte. Disregard the values ​​previously reported through the tables included in the kits.

Device

Trade Name: HDL DIRECT - PP 400 /// registration: 80022230071. /// Model //// Lot: 5003; 5004 and...

Manufacturer

Gold Analisa Diagnóstica Ltda.
  • Source
    ANVSANVISA