Events

TCAutomation / enGen Laboratory Automation 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-2015-RN-00423-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00423-1
  • 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
    Recapped tubes can lean in their storage holes, causing them to touch neighbouring tubes and interfere with the movement of the robot gripper. the gripper does not have enough space to properly place the tubes in the storage racks due to leaning tubes in the racks. there is a potential for the caps to fall off of or be knocked from sample tubes placed in the storage racks of entry/exit modules. there is also the possibility for the gripper to grab a tube at the wrong height and drop the tube in the entry/exit modules. these situations may result in splashing of bio-hazardous fluid, and sample cross-contamination may occur if there is an uncapped tube in the rack.
  • 조치
    The rack profile configuration has been modified in a way that tubes are loaded to only every second position. Because existing rack is used, this does not require new software release for TCA. This modified rack profile configuration will prevent tubes to lean too close to the next one while loading it and thus preventing possible collision. Thermo Fisher is recommending their customers to install the modified rack profile configuration. Installation of the modified rack profile can be done by authorised service engineer. Thermo Fisher will release a new version of storage cap which has bevelled upper part to ease gripper and tube movements. Release is expected in a few months.

Device

TCAutomation / enGen Laboratory Automation Systems. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    TCAutomation / enGen Laboratory Automation Systems. An in vitro diagnostic medical device (IVD)Product Code: ENGENRecapper CapsProduct Code: 952238 or 6844286 onlyRecapper Module (230V) or Recapper Module (110V) Product Code: 952036-EG or 952136-EGRack Entry and Exit Module and/or Rack Exit ModuleProduct Code: 952020-EG/6844086 or 952019-EG/6844103Storage Rack Slim 100 positions or Storage Rack 180 positions:Product Code: 952075 or 952073
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics