Events

Product name: ID-DiaClon Anti-N (MNS2) and ID-DiaClon Anti-M / -N /// Registration number: 80004040126 /// Lots: 50221.73.01 and 50221.73.03 (D-DiaClon Anti- N (MNS2) (REF 007111)) / / Product hazard class: III. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 DiaMed Latino América S.A.; Diamed 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
    1864
  • 날짜
    2016-04-15
  • 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
    In specific situations, negative samples may be interpreted as positive. However, as mentioned in "conclusions of the risk assessment" there is no risk to the patient.
  • 원인
    The anti-n component of the products id-diaclon anti-n (mns2) and id-diaclon anti-m / -n, in specific conditions, may present unexpected interference with samples that do not have corresponding antigen (n negative).
  • 조치
    Action code: AC 2016/01 /// The field action consists of issuing IMPORTANT FIELD COMMUNICATION /// The company recommends "not validate any positive result that presents a reaction whose force is less than 3 (according to images of the important communiqué field - annex). Negative and positive results with forces between 3+ and 4+ can be validated unconditionally. If the automatic validation function of the equipment is being used, disable the function, especially when the tests - mo45d and pr44n - are performed, because in that situation such interference can be interpreted as positive by the system. This implies that the above tests must be run separately, since it is not possible to disable automatic validation only for these two tests. The test should be repeated for results that are not clearly positive or negative. If the results are not clearly negative, the test should be repeated using an alternative method (id-profile iii). / / LETTER TO THE CLIENT IN ANNEX.

Device

Product name: ID-DiaClon Anti-N (MNS2) and ID-DiaClon Anti-M / -N /// Registration number: 800040...

Manufacturer

DiaMed Latino América S.A.; Diamed GmbH