Events

Xpert BCR-ABL Monitor Technical Name: Chromosome Translocation BCR-ABL Registration Number ANVISA: 81062710016 Hazard Class: III Affected Model: Kit with 10 tests (cartridges with integrated reaction tubes) Serial numbers affected: LOT: 1000041807 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 CEPHEID BRASIL IMPORTAÇÃO, EXPORTAÇÃO E COMÉRCIO DE PRODUTOS DE DIGANÓSTICOS LTDA.; CEPHEID 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
    2311
  • 날짜
    2017-06-13
  • 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 proposed action to address device failures is to send customers a Field Security Notification (FSN), which informs customers to stop using the BCR-ABL Monitor product, lot 1000041807, which will later be collected by the company.
  • 원인
    A new test method for bcr-abl monitor shows that performance deteriorates after 12 months when stored at 2-28 ° c. the d10939 rev k stability report reduces the stability validity from 24 months to 12 months for the xpert bcr-abl monitor products. analysis of the mode of failure of bcr-abl in relation to the impact of the product result on the patient: stability data from the assay beyond 13 months sub-reported the amount of bcr-abl mrna transcript at the lowest level tested, 1%. the reported performance of the xpert bcr-abl monitor assay allows a 2-fold variance in the ratio of bcr-abl mrna transcripts to abl, considering that at 25 months, we observed a 3-fold difference. at 13 months, a variance of 1.8 times was observed, which is within the variability of performance of the declared product. although beyond the stability limits, the detected level of transcription of bcr-abl mrna is correctly termed as the bcr-abl detected.
  • 조치
    Field Action Code CPHD-002/2017 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Company will collect for further destruction of the product.

Device

Xpert BCR-ABL Monitor Technical Name: Chromosome Translocation BCR-ABL Registration Number ANVISA...

Manufacturer

CEPHEID BRASIL IMPORTAÇÃO, EXPORTAÇÃO E COMÉRCIO DE PRODUTOS DE DIGANÓSTICOS LTDA.; CEPHEID