Events

VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 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-2018-RN-00604-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00604-1
  • 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
    Ortho has confirmed customer complaints regarding the potential for imprecise results when using impacted vitros phyt slides. the results obtained were either positively or negatively biased across the vitros phyt slides measuring range of 3.00–40.00 ug/ml (11.88–158.40 umol/l).To date, no adverse events have been reported as a result of this issue.
  • 조치
    Ortho is requesting customers to immediately discontinue using and discard all remaining inventory of VITROS PHYT Slides for the affected lots. Ortho will replace remaining inventory of the affected lots or credit accounts.

Device

VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).Unique Identifier Number:10758750004690Product Code: 8298671Generation: GEN 16Coating ID: Coating 0165Multiple Lot NumbersExpiry date:15 March 2018 through to 15 June 2018ARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd