Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Beckman Coulter 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-2015-RN-01204-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-09
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    During internal testing, it was determined that the software for various dxh systems allows for the creation of multiple orders with the same specimen identification (id), but a different patient identification when manually editing pending orders at the system manager.This issue does not occur for edits of released results or for test orders requested through host transmission.There is a possibility of sample misidentification and the release of erroneous results.
  • 조치
    Beckman Coulter is advising users not to edit the Specimen ID for a pending test order at the System Manager's Worklist. A software upgrade will be available to correct the issue. This action has been closed out on 13 Jun 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. An in vitro diagnostic medical device (IVD)Unicel DxH 800 Coulter Cellular Analysis SystemReference Numbers: 629029, B24465 and B24802Software version: 3.0.2.0Unicel DxH SMS Coulter Cellular Analysis SystemReference Numbers: 775222Software version: 3.0.2.0Unicel DxH 600 Coulter Cellular Analysis SystemReference Numbers: B23858Software version: 1.1.1.0ARTG Number: 177999
  • Manufacturer

Manufacturer