Events

Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Inverness Medical Innovations Australia Pty Ltd T/A Alere 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-2014-RN-01289-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-12-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01289-1
  • 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
    In certain cases an inratio & inratio2 pt/inr monitor system may provide an inr result that is clinically significantly lower than a result obtained using a reference inr system (laboratory method). this issue can arise if the patient has certain medical conditions.Br /br /further information has been published on the tga website at - http://www.Tga.Gov.Au/alert/alere-inratio-ptinr-monitor-system .
  • 조치
    Alere is advising consumers and healthcare professionals of the additional warnings and precautions required when using the INRatio & INRatio2 PT/INR Monitor systems. Consumers are requested to consult their doctor to determine if any of the following conditions apply to them: - Anaemia (haematocrit < 30%) - chronic inflammatory conditions - severe infection - advanced stage cancer or end stage renal disease - any bleeding or unusual bruising. This action has beenclosed-out on 06/07/2016.

Device

Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD)INRatio Test Strips Reference Numbers: HS0100071, HS0100139, HS099007EU, HS99007G1, HS099008EU, HS99008G1Multiple Product DescriptionsARTG Number: 216755INRatio2 Monitors Reference Numbers: HS0200431, HS200433SJM, HS200433SJMK, HS0200433Multiple Product DescriptionsARTG Number: 214252
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • Manufacturer
    Inverness Medical Innovations Australia Pty Ltd T/A Alere

Manufacturer

Inverness Medical Innovations Australia Pty Ltd T/A Alere
  • 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
    DHTGA