Events

VITROS Vapor Adsorption Cartridge. 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-00061-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-01-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00061-1
  • 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
    There is the potential for vitros vapor adsorption cartridges sales unit cartons to incorrectly contain a particulate cartridge (part number j19612).
  • 조치
    Ortho Clinical Diagnostics (OCD) is requesting end users to ensure that a VITROS Vapour Adsorption Cartridge is installed. If a Particulate Cartrtigde is installed it must be replaced immediately with the correct cartridge and reported to OCD Customer Technical Services. Results generated while a Particulate Cartridge was installed must be reviewed. Any concerns with previously reported patient results should be discussed with the laboratory director to determine the appropriate course of action.

Device

VITROS Vapor Adsorption Cartridge. An in vitro diagnostic medical device (IVD).

Manufacturer

Ortho-Clinical Diagnostics