Events

VITROS 3600 and 5600 Systems using Software Version 3.2 and Below. 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-01098-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01098-1
  • 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
    Due to a software anomaly, the temperature in the well wash module may be out or range without notification to the operator.Temperature monitoring is performed by the vitros system for each subsystem (i.E. microslide, microtip and microwell). ortho-clinical's investigation confirmed that under very specific conditions, the temperature for the well wash module may be out of range without alerting the operator..If the anomaly occurs, it is possible for the vitros system to process samples outside of the proper temperature range, potentially leading to biased patient result. the results will not have the proper ‘wt’ (wash temperature) result code.
  • 조치
    Ortho-Clinical is providing users with a guide to determine if the unit is affected by the temperature issue. If a temperature is out of range and the status bar indicates that the system is “Ready” or the temperature icon is NOT present, the user is advised to contact the sponsor’s Technical Solutions Centre. Ortho-Clinical is advising users to discuss any concerns regarding previously reported results with the Laboratory Director. This action has been closed-out on 29/08/2016.

Device

VITROS 3600 and 5600 Systems using Software Version 3.2 and Below. An in vitro diagnostic medical...
  • 모델명 / 제조번호(시리얼번호)
    VITROS 3600 and 5600 Systems using Software Version 3.2 and Below. An in vitro diagnostic medical device (IVD)VITROS 3600 System Product Code: 6802783VITROS 3600 System Software Version 3.2 & BelowProduct Code: 6802866VITROS 5600 SystemProduct Code: 6802413VITROS 5600 System Software Version 3.2 & BelowProduct Code: 6802864ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics