Events

ARCHITECT STAT TROPONINA-I REAGENT KIT .. Registration at Anvisa: 80146501213. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott Laboratórios do Brasil Ltda 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
    874
  • 날짜
    2007-07-09
  • 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
    The US FDA has sent a letter of communication to Anvisa informing about a Class 1 recall alert, issued in that country, involving the product ARCHITECT STAT TROPONINA-I REAGENT. The diagnostic test in question is used to quantify Troponin-I protein, which is produced by the human body after a heart attack. The purpose of this test is to obtain indications for cardiac infarction in patients who have suffered from chest pain in a recent period. In communication with Anvisa, Abbott Laboratories do Brasil Ltda reported that the value of Cut Off (parameter used to define whether or not there is a change in the patient's cardiac condition) normally used in Brazil is 0.3ng / mL, higher than 0 , 1ng / mL.
  • 원인
    The analytical sensitivity of 0.01ng / ml of the architect stat troponin-i reagent diagnostic test may not be checked on all batches of the product. in this way, false-negative results can occur with results lower than 0.1ng / ml (functional test sensitivity) for all batches of this diagnostic test.
  • 조치
    According to information provided by the company Abbott Laboratories do Brasil Ltda, the necessary actions for this case by the users are the following: (a) For laboratories or doctors that use a band less than or equal to 0.1 ng / mL as cut -off, samples should be retested and / or serial blood collections negative, over time, should be evaluated before patients are classified as negative for heart attack; (b) Recent negative results less than 0.1 ng / mL should also be reassessed and the physicians who requested the examination request should be notified; (c) Laboratory reports with negative results less than 0.1 ng / mL should contain the observations of attention in the points of the previous items, alerting health professionals that small elevations of Troponin-I may be lost by the ARCHITECT STAT TROPONIN-I assay and that those negative results do not rule out the possibility of low troponin-I elevations; (d) If the health care professional has sent a consignment of ARCHITECT STAT Troponin-I to another laboratory, it shall communicate this information about the diagnostic kit to such laboratory. Abbott Laboratories of Brazil Ltda also informed Anvisa that it has already sent letters of communication reporting the problem to all customers who received the product.

Device

ARCHITECT STAT TROPONINA-I REAGENT KIT .. Registration at Anvisa: 80146501213.

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA