Events

MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Thermo Fisher Scientific 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-2018-RN-00596-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-05-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00596-1
  • 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
    The control's open-vial stability claim for all constituents is "once opened, vials of chemtrak - h are stable for 14 days when stores tightly capped at 2-8deg c". the manufacturer has confirmed that one constituent of the control, glucose, does not meet this stability claim as the recovery of this constituent trends down prior to the stated open-vial usage. the open-vial stability claim of 14 days remains unchanged for the other glucose levels, chu20022a and chu20023a.
  • 조치
    Thermo Fisher are advising customers to continue to use Level 1 of the chemTRAK control after the initial thaw for a period of 5 days and discard the control after this period.

Device

MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD). Catalogue Number: CHU-1Lot Number: CHU20021AARTG Number: 192625(Thermo Fisher Scientific Australia Pty Ltd - Multiple clinical chemistry constituent IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd