Events

Software of IRIDICA Controller, version 2.1be instrument IRIDICA BB (Bead Beater), reference number 08N26-010 를 위한 리콜 또는 안전성 경고

Agencia Española de Medicamentos y Productos Sanitarios (Via FOI)에 따르면, 해당 리콜 또는 안전성 경고 는 Spain 에서 Abbot Molecular Inc. 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
    Recall / Safety Alert
  • 날짜
    2017-04-06
  • 사례 국가
    Spain
  • 사례 출처
    AEMPSVFOI
  • 비고 / 경고
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • 데이터 추가 비고
  • 조치
    Possibility of obtaining incorrect results with the IRIDICA systems, manufactured by Abbot Molecular Inc, United States, due to a problem with version 2.1b of the IRIDICA Controller software that affects the IRIDICA BB instrument.

Device

Software of IRIDICA Controller, version 2.1be instrument IRIDICA BB (Bead Beater), reference numb...

Manufacturer

Abbot Molecular Inc.
  • 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
    AEMPSVFOI