Events

Product Name: Family Reagents for Immunohematology -Complementary Reagents- DIAMED //// Model: ID-DAT IgG - DILUTION - 004033 - Record Number: 80004040133 - Hazard Class: II - Lots: ID-DAT IgG - Dilution (REF 004033 ) Lot 50870.29.02 and ID-DAT IgG-Dilution (REF 004033) Lot 50870.30.01. 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
    1565
  • 날짜
    2015-04-30
  • 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
    The company recommends "DISCONTINUE USING THE PRODUCT".
  • 원인
    Dilution (ref 004033) batch 50870.29.02 and id-dat igg - dilution (ref 004033) batch 50870.30. dilution of product reactivity, identified by means of the monitoring of the stability performed in samples of retention of id-dat igg. 01. according to the company, "the division mentioned can affect the evaluation of the hemolysis risk in the following situations: • monitoring the patient with hemolytic anemia auto-imune (aiha) • monitoring hemolytic disease in newborns • other investigations for dat positives considering used laboratory practices and the intended use of this product, the results obtained from this product should not be considered isolately but associated with the patient's clinical condition, his medical history, in addition to other relevant laboratory data. in the instruction for use accompanying the product ".
  • 조치
    The company is communicating its clients (IN THE ANNEX LETTER TO THE CLIENTS AND MAP OF DISTRIBUTION) and carrying out the Recolhimento for the destruction of the lots under risk in Brazil. Code: AC 2015/01

Device

Product Name: Family Reagents for Immunohematology -Complementary Reagents- DIAMED //// Model: ID...

Manufacturer

DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH