Events

enGen Laboratory Automation Systems, 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-2015-RN-00328-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00328-1
  • 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 (ocd) is advising users of a software anomaly regarding the routing of urine samples which required pre-treatment for assays using vitros chemistry products ca, mg and phos slides. the engen system software currently does not route samples which require acidification pre-treatment to the manual high priority exit location for pre-treatments as intended. in addition, the engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pre-treatment. ocd internal testing has confirmed instances where vitros 5,1 fs, 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen, regardless of the pre-treatment requirements for each selected assay, potentially leading to biased patient results.
  • 조치
    OCD is providing temporary work around instructions for users to prevent the failure mode. A software update will be implemented as a permanent fix. Also, OCD is advising users to discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 11/08/2016.

Device

enGen Laboratory Automation Systems, An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    enGen Laboratory Automation Systems, An in vitro diagnostic medical device (IVD)Affected Versions: Systems configured with enGen Select v5.0 and Custom or Select v3.2.2 and belowProduct Code: ENGEN
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics