Events

Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Dako Australia Pty Ltd 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-2012-RN-01198-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-12-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01198-1
  • 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
    Based on an investigation it has been concluded that the expected lifetime of the coverstainer racks does not meet the set requirements. the consequence can be that slides are falling out of the rack during the staining process. slides falling out of the rack during the staining process would require a new slide preparation and staining process to be initiated. in the rare event, the patient may need to be called in for a new sample to be taken.This recall action was not notified to the tga before it was initiated by dako australia.
  • 조치
    Dako Australia Pty Ltd has advised their customer to discontinue use and return the Coverstainer Slide Racks for replacement.

Device

Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)Model number: CS10330ARTG: 181957
  • Manufacturer
    Dako Australia Pty Ltd

Manufacturer

Dako Australia Pty Ltd