Events

VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry 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-2013-RN-01270-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01270-1
  • 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
    While performing an on-analyser dilution, some customers have reported an increase in eae condition codes (sample metering dilution error). the data indicates that the rate of occurrence for eae codes can vary between 2 and 25% for cups within the affected arrays. when an eae condition code occurs, the processing for that sample is automatically cancelled by the system.Ortho-clinical diagnostic's investigation into the increased rate of eae condition codes determined that some of vitros mixing cup arrays may be out of specification.
  • 조치
    Ortho-Clinical Diagnostics is advising their customers to continue using the Mixing Cup arrays as there is currently no alternative available. It is recommended that laboratories perform manual dilutions for samples with low volume rather than using an onboard dilution. This action has been closed-out on 10/02/2016.

Device

VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. An in vi...
  • 모델명 / 제조번호(시리얼번호)
    VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. An in vitro diagnostic medical device (IVD).Product Code: 1631779ARTG Number for VITROS Chemistry Systems:180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics