Events

ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software version 2.12.10 (for ORTHO BioVue Cassettes). 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-2016-RN-00286-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00286-1
  • 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 clinical diagnostics is issuing this notice due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a reagents load/unload request. if an unexpected change is made in a load station location that was not selected via the graphical user interface (gui), the system will not detect the change. if users deviate from normal process for changing patient samples, these can be associated with another sample id, potentially leading to erroneous test results. in the unlikely event the error occurred, it may lead to an incorrect rh(d) or incorrect cross matching result. there have been no reports of patient injury.Update: ortho has advised an additional unlikely scenario where it is also possible for a user to unexpectedly remove or interchange diluents in a location that was not selected on the graphical user interface (gui) after making a reagents load/unload request.
  • 조치
    Ortho Clinical Diagnostics is advising users to ensure samples, diluents and dilution trays are loaded and unloaded using the Graphical User Interface (GUI). The issue will be addressed in a future software version. Any concerns regarding previously generated results should be discussed with the Laboratory Director. This action has been closed-out on 02/02/2017.

Device

ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software ve...
  • 모델명 / 제조번호(시리얼번호)
    ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software version 2.12.10 (for ORTHO BioVue Cassettes). An in vitro diagnostic medical device (IVD)ORTHO VISION Analyser for ORTHO BioVue Cassettes Software Versions: 2.12.6 and below Product Code: 6904579ORTHO VISION Max Analyser for ORTHO BioVue CassettesSoftware Versions: 2.12.10Product Code: 6904578ARTG Number: 229946
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics