Events

RealTime High Risk HPV Assay and RealTime High Risk (HR) HPV m2000 system ROW Combined Application CD-ROM 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Abbott 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
    Safety alert
  • 날짜
    2013-12-02
  • 사례 출판 날짜
    2013-12-02
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131202.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: abbott realtime high risk hpv assay and realtime high risk (hr) hpv m2000 system row combined application cd-rom medical device manufacturer, abbott molecular inc., has issued a medical device safety alert concerning its realtime high risk hpv assay and realtime high risk (hr) hpv m2000 system row combined application cd-rom [list no.: 02n09 and 4n05-01; version 1.0 of the realtime high risk (hr) hpv m2000 system row combined application cd-rom] according to the manufacturer, m2000rt instrument noise is defined as an unexpected cycle-to-cycle variability in the fluorescence signals during the amplification and detection process. the manufacturer has identified that the instrument noise lower limit validity parameter for the realtime hr hpv assay is set outside of the optimal setting to flag excess variability in fluorescence signal. therefore, in the presence of excess noise, incorrect results could be generated. it is normal for instruments to have some variability in fluorescence signal (noise). however, one factor that could contribute to excess instrument noise is m2000rt lamp issues. a resolution has been identified and requires a change to the instrument noise validity parameter for realtime hr hpv assay. the manufacturer will correct the issue in the next version of the assay software. affected users are recommended to follow the technical solutions mentioned in the field safety notice until an upgrade to the new software can be installed. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 02 december 2013.

Device

RealTime High Risk HPV Assay and RealTime High Risk (HR) HPV m2000 system ROW Combined Applicatio...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Abbott RealTime High Risk HPV Assay and RealTime High Risk (HR) HPV m2000 system ROW Combined Application CD-ROM
  • 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
    DH