Events

Trade name: Nuclisens Lysis Buffer. Technical Name: Nuclisens Lysis Buffer. ANVISA Registration Number: 10158120527 Hazard Class: I Affected Model: Not applicable Serial Numbers Affected: 16092902 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
    2230
  • 날짜
    2017-03-17
  • 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
    Destroy the remaining stock of units in lot 160092902 of Nuclisens Lysis Buffer that are still in stock. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client. There was no product distributed in Brazil.
  • 원인
    It was identified, after receiving customer complaint, colored eluents for extractions of whole blood when using the nuclisens batch lysis buffer: 16092902. due to this fact an investigation was opened in the laboratory of research and development related to this product (pr 1082674). open investigation (pr1082674) has confirmed that the eluent becomes colored due to the presence of hemoglobin in the blood samples, including dry blood spot. in the case of dry blood spot, the investigation highlighted some cases of inhibition even though the eluents remain slightly colored. the root cause of the staining is linked with a non-compliance in terms of ph value of the lysis solution. it has been found that the ph of the solution in this batch is 6.9 when the ph specification for this solution is 7.1 +/- 0.1. research has confirmed that the presence of hemoglobin may cause inhibition of downstream applications (pcr / rtpcr / nasba etc ....), resulting in uninterpretable results in most cases. because the internal controls would also be inhibited, we would invalidate the test. in this case the risk is related to the delay in the emission of the diagnostic results. however, considering that the nuclisens lysis buffer is used in various protocols and downstream applications; and assuming a conservative positioning, we can say that the worst case scenario would be: internal control is not inhibited or not used, although this is part of the good laboratory practice procedures, the color eluent tests could have a potential result false negative investigations have confirmed that we have no other batch of the nuclisens lysis buffer on the market today presenting the same problem of non-compliance with ph.
  • 조치
    Field Action Code FSCA 3337 triggered under the responsibility of the company bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda. Company will not do any field action because no kit was put on the market.

Device

Trade name: Nuclisens Lysis Buffer. Technical Name: Nuclisens Lysis Buffer. ANVISA Registration N...

Manufacturer

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