Events

TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). 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-2016-RN-00352-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00352-1
  • 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 electrical cable that supplies power to the cap vibratory feeder of the recapper module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. if this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.G., serum) may splash from the tube and into another tube or onto the under carriage of the support plate. this may result in contamination of patient samples and affect patient diagnosis or treatment.
  • 조치
    Ortho Clinical is advising users to check the affected systems to identify if the electrical cable has migrated out of position. A Service Representative will secure the cable in place above the support vibration feeder plate. This action has been closed-out on 09/05/2017.

Device

TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An i...
  • 모델명 / 제조번호(시리얼번호)
    TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An in vitro diagnostic medical device (IVD)TCAutomation SystemProduct Code: 6844300Thermo Scientific Recapper Module (230V)Product Code: 952036
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics