Events

Labscreen Multi HLA Class I and III and HNA Technical Name: Labscreen Multi HLA Class I and III and HNA Registration Number ANVISA: 80298490004 Hazard Class: III Affected Model: LSMUTR Affected Series Numbers: Lot: 007 Batch: 0000091458 , 0000099706 and 0000145845 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biometrix Diagnóstica Ltda.; One Lambda, 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
    2289
  • 날짜
    2017-05-16
  • 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
    Actions to be taken: User guidance to use the Instructions for Use LABScreen Revision 9 (LMMUTRPI Ver 9), which can be consulted on the One Lambda website, and discontinue the document LABScreen Multi Revision 8 (LMMUTRPI Ver 8). If the product was analyzed using LABScan 3D (Luminex FM3D), reanalyze the results using LABScan 100 (Luminex 100/200) to ensure the accuracy of the results.
  • 원인
    Field action code 2018 triggered under the responsibility of the company biometrix diagnostica ltda. company will update, amend or supplement the instructions for use. the manufacturer has notified the distributor that the instruction for use of the labscreen multi hla class i and ii and hna (lsmutr) product containing divergent required instrument information has been released. the code usage instruction lmmutrpi ver 8, released on 04/20/2016 contained as required instrument the labscan 3d equipment, however the required instrument is the labscan 100. the product works as indicated, this error is for documentation only.
  • 조치
    Field Action Code 2018 triggered under the responsibility of the company Biometrix Diagnostica Ltda. Company will update, correct or supplement the instructions for use.

Device

Labscreen Multi HLA Class I and III and HNA Technical Name: Labscreen Multi HLA Class I and III a...

Manufacturer

Biometrix Diagnóstica Ltda.; One Lambda, Inc.
  • Source
    ANVSANVISA