Events

ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 ABBOTT GMBH & CO. KG CON DOMICILIO EN || ALEMANIA. || Imported by: ABBOTT LABORATORIES DE COLOMBIA 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
    RRD-031216
  • 사례 연번
    INVIMA 2011RD-0002106
  • 날짜
    2016-12-12
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=110
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    Abbott has identified a problem of specific stabilities of the reagent lots 10533up00 and 10535up00. as the reagent approaches the expiration date, the values in relative units of light (url) of the calibration curve decrease, causing the results of patients calculated with this diminished curve to rise excessively, resulting in false patient results. the controls may not reflect the instability of the reactive, since the recalibration can make the values of the controls are within the acceptable ranges.

Device

ARCHITECT ACTIVE B12 (HOLOTRANSCOBALAMIN) REAGENT KIT

Manufacturer

ABBOTT GMBH & CO. KG CON DOMICILIO EN || ALEMANIA. || Imported by: ABBOTT LABORATORIES ...
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA