Events

Nuclisens Magnetic Silica Technical Name: Nuclisens EasyMAG Magnetic Silica ANVISA Registration Number: 10158120569 Hazard Class: I Affected Model: Not applicable Serial Numbers Affected: Z017KB1MS / Z017LE1MS / Z017MA1MS and Z017NA1MS 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 bioMérieux Brasil Indústria e Comércio de produtos Laboratoriais Ltda.; bioMérieux S.A. 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
    2183
  • 날짜
    2016-12-09
  • 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
    Required actions: We request the following actions at the moment: - Please distribute this information to all appropriate personnel in your laboratory, keep a copy in your files and send this information to all parties who may use this product, including others who you may have downloaded our product. - Systematically use an internal extraction control that mimics the extracted target (with the same nature / structure) and / or external controls as recommended in the product manual and in the Laboratory Good Practices to detect any extraction problems. - In case of problem detected, reduce the sample inlet volume to 200μl. Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Officer to determine the appropriate course of action. Please contact bioMérieux customer service if you notice the problem. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the completion report of the field action proving the sending of the customer safety warning with evidence from science and all actions completed.
  • 원인
    The problem was detected during additional control done on batches made of nuclisens easy mag magnetic silica (tests outside the manufacturer's quality control routine procedures). this additional test is a bk virus run application (amplification method) used to mimic the worst-case condition of a vol. above 1ml of specimen and a small-sized (5kbp) double-stranded genome. in addition the performance of the batches that were released was monitored in real-time stability at 02 levels: 1- in the worst case situation, in a bk test and 1ml of specimen. 2- with representative tests of biomérieux applications (rna & dna, argene line and nuclisens line). monitoring of performance, it was observed that after a few months of validity, there is a drift in the performance results with the bk test and 1ml of plasma (bk virus, worst case of application); for some batches nuclisens easymag magnetic silica. the observed performances for biomérieux applications, including the bkvirus r-gene (ref. 69-013b), remain in place over time when such applications are used in accordance with their instructions for use.
  • 조치
    Field Action Code FSCA3203 triggered under the responsibility of bioMérieux Brasil Indústria e Comércio de productos Laboratoriais Ltda. Company will send guidance letter to clients.

Device

Nuclisens Magnetic Silica Technical Name: Nuclisens EasyMAG Magnetic Silica ANVISA Registration N...

Manufacturer

bioMérieux Brasil Indústria e Comércio de produtos Laboratoriais Ltda.; bioMérieux S.A.