Events

VITROS Chemistry Products MicroSlides (an in vitro diagnostic medical device (IVD)) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 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-00773-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-07-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00773-1
  • 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
    The vitros microslide cartridge is made up of the cartridge body and an anti-backup platen (abp). the purpose of the abp is to keep the stacks of slides in the correct position for dispensing. ortho clinical diagnostics have received reports associated with abp failing to advance, jamming or failing to stay locked in place within the cartridge. when this occurs, the slide is not properly dispensed from the cartridge since the stack of slides is not positioned correctly.
  • 조치
    Ortho Clinical is providing users with work around instructions to resolve slide dispense issues. Users are advised to replace the affected unit and contact Ortho Clinical for a replacement if they are unable to resolve a slide dispense issue by repositioning the ABP. This action has been closed-out on 12/02/2016.

Device

VITROS Chemistry Products MicroSlides (an in vitro diagnostic medical device (IVD))
  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products MicroSlides (an in vitro diagnostic medical device (IVD))Multiple catalogue numbers affectedExpiry dates to 22 March, 2015ARTG Number: 25922
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics