Events

IMx Kit B12 Reagent No. batch 75782M200 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott Laboratórios do Brasil LTDA - Divisão Diagnósticos 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
    711
  • 날짜
    2002-07-25
  • 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 investigation of this issue is under way. Abbott, is working to speed up the replacement of the IMx B12 reagent product No. batch 75782M200, so we recommend alternative methods for performing the test. For more information contact your local representative or directly with Abbott Laboratories of Brazil LTDA - Diagnostics Division (0xx11 ) - 5536.7000
  • 원인
    Studies with the reagent imx b12 assay no. batch 75782m200, performed by abbott laboratories, have demonstrated that calibration failure, non-limiting controls, and non-reproducibility of patient outcomes may occur.
  • 조치
    . Review the results of the controls for the reagent IMx B12 assay No. lot 75782M200. . Discontinue use of reagent IMx B12 batch No. 75782M200 verify that the results of the low control are out of range as recommended in the package insert. If the low control is off (above and below the limits for low control), it is recommended to retest patients with results inconsistent with the clinical evaluation made by the physician. If the low control is within the limits described in the package insert, no action of retesting the patient results is necessary. . No action is required for the Medium and High controls.

Device

IMx Kit B12 Reagent No. batch 75782M200

Manufacturer

Abbott Laboratórios do Brasil LTDA - Divisão Diagnósticos
  • Source
    ANVSANVISA