Events

i-STAT PT/INR Cartridges(prothrombin time test) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Abbott Australasia Pty Ltd Point-of-Care Division 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-2015-RN-00549-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00549-1
  • 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
    Abbott point of care inc. (apoc) has determined that certain lots of i-stat pt/inr cartridges may generate a higher than typical number of pt/inr star outs, due to the internal quality system suppressing results if the analyser or cartridge does not meet certain internal specifications. there is a potential to delay the generation of patient results for pt/inr due to the star outs. when results are generated they are within the expected performance of the assay.
  • 조치
    Cartridges can continue to be used for patient testing. If you repeatedly observe the condition where cartridges from the lots listed above display star outs, please contact Abbott Customer Support for your country and they will organise replacement of impacted stock. This action has been closed-out on 02/05/2017.

Device

i-STAT PT/INR Cartridges(prothrombin time test)
  • 모델명 / 제조번호(시리얼번호)
    i-STAT PT/INR Cartridges(prothrombin time test)List Number: 03P89-24Lot Number: All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusiveARTG Number: 213851
  • Manufacturer
    Abbott Australasia Pty Ltd Point-of-Care Division

Manufacturer

Abbott Australasia Pty Ltd Point-of-Care Division
  • 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