Events

CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Roche Diagnostics Australia Pty Limited 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
    RC-2013-RN-00415-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-05-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00415-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Roche has discovered that in rare cases (<0.00015%) an “error 6” may also be displayed by individuals who are under treatment with warfarin in combination with antibiotics and/or chemotherapeutics. in such patients inr values could be extremely high (>10 inr). the coaguchek displays the various codes when it suspects there could be a problem with the actual measurement of your inr. "error 6” when shown in the display represents alerts to a number of issues with the testing.
  • 조치
    In the event of an "error 6" end users are advised to repeat the test and if the error continues contact their physician immediately. The package insert for the CoaguChek XS PT strips will be updated to contain this information. For more information, please see http://www.tga.gov.au/safety/alerts-device-coaguchek-inr-monitors-130516.htm .

Device

CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD)Material numbers: 04796179001, 04811500001, 04963733001, 06505597001, 04800842190, 05864640001, 06505589001, 06644511001, 05530199190
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited