Events

Abbott RealTime High Risk HPV and RealTime High Risk (HR) HPV Application CD-ROM (for m2000 System) 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Abbott Molecular Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    15700
  • 사례 시작날짜
    2013-11-21
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Abbott Diagnostics Division, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, AUCKLAND 1640
  • 원인
    M2000rt instrument noise is defined as an unexpected cycle-to-cycle variability in the flurorescence signals during the amplification and detection process. abbott molecular has identified that the instrument noise lower limit validy parameter for the realtime hr hpv assay is set outside of the optinal setting to flag excess variability in fluroescence signal. therefore, in the presence of excess noise, incorrect results could be generated.
  • 조치
    Software to be upgraded

Device

Abbott RealTime High Risk HPV and RealTime High Risk (HR) HPV Application CD-ROM (for m2000 System)
  • 모델명 / 제조번호(시리얼번호)
    Model: List Numbers: 02N09 & 4N05-01, Affected: Version 1.0
  • Manufacturer
    Abbott Molecular Inc

Manufacturer

Abbott 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
    NZMMDSA