Events

Name of reagent: Red cell Reag family for Immunohematology R4 - IH Biovue - Other items in Annex 1 Technical name: Reag for immunohematology - Red cell reagent / enzyme-treated red cell number ANVISA registration number: 80145901444 Hazard class: : Surgiscreen -Conj of 3 vials with 3mL each of cel for detection of unexpected antibodies Serial numbers affected: 3SS214Z; 3SS216Z; 3SS222Z; 3SS225Z; 3SS231Z; 3SS238Z; 3SS241Z; 8EA329; 8RA330; 8RA331; 8SS282; 8SS284; 8SS285; 8SS286; 8SS271; 8SS272; 8SS273; 8SS274; 8SS275; 8SS276; 8SS277; 8SS278; 8SS279; 8SS280; 8SS281; 8RC306; 8RC307; 8RC308; 8S893; 8S894; 8S896; 8ª511; 8ª512; 8ª222; 8ª523; 8,548; 8ª534. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics Inc. 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
    2114
  • 날짜
    2016-12-02
  • 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
    • Visually inspect all products before use according to the Instructions for Use. Do not use red cell products if marked haemolysis or evidence of contamination is observed. • Contact the Ortho Care ™ Technical Solutions Center to report a product in which marked haemolysis has been observed so that the product can be replaced or credited. • Complete and return the Receipt Confirmation form.
  • 원인
    Ortho clinical diagnostics received a large number of customer complaints and confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products, as well as quality control products containing red blood cells. ortho conducted extensive research and the root cause for marked haemolysis was identified as microbial contamination.
  • 조치
    Field Action Code 16000162 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

Name of reagent: Red cell Reag family for Immunohematology R4 - IH Biovue - Other items in Annex ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics Inc.