Events

DUOLYS, IMUNOHEMATOLOGY - ABO - MONOCLONAL ORIGIN, record 10154450118, model: 12 DuoLys microplates for 12 x 8 ABO-RH1 typing and RH-K phenotypes (each microplate contains 8 wells of Anti-A, Anti-B, Anti-A, B , Anti-E, Anti-E, Anti-K, Negative Control and 2 x 8 empty wells) + 1 vial of 40 ml of MagneLys, hazard class IV, lots: PhenoLys for 12 x 16 RH-K phenotypes (each microplate contains 2 x 8 wells of negative control, 2 x 8 negative control wells, Anti-C, Anti-E, Anti-c, Anti-e, Anti-K) + 1 vial of 40 ml MagneLys, hazard class IV, batches: 618000, 619000, 620000. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Fresenius Homecare Brasil Ltda.; DIAGAST 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
    1818
  • 날짜
    2016-02-10
  • 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
    The Brazilian population is very heterogenous, and some specific population groups have distinct variants of Anti-RH5, which can lead to some false negative results when using the product. As these cases are very rare, it is difficult to identify them, the company in becoming aware of this possibility, is suggesting the use of a complementary method for the identification of this antigen.
  • 원인
    Fresenius kabi has identified a divergence in the results of some samples of the duolys and phenolys products, which are used for phenotyping the rh + k system in laboratories and blood banks in the freelys nano and qwalys equipment. we have noticed that some samples of the product have failed to detect the antigen "e" (one of the antigens that is part of the kit profile). clones of the anti-and impregnated monoclonal reagent in the wells of these microplates are ms63 and p3gd512.
  • 조치
    Availability of a reagent Soroclone Anti-e, of monoclonal origin, for tube testing. Action code: 01-2016. As a preventive measure, the phenotype is repeated for the antigen "e", in all cases where the result obtained in the microplate is negative for said antigen. For this, Fresenius Kabi will be supplying, together with the DuoLys and PhenoLys kits, the monoclonal reagent Soroclone Anti-e, for tube testing, prepared from clones MS26 + MS21 + MS63.

Device

DUOLYS, IMUNOHEMATOLOGY - ABO - MONOCLONAL ORIGIN, record 10154450118, model: 12 DuoLys microplat...

Manufacturer

Fresenius Homecare Brasil Ltda.; DIAGAST