Automatic Quality Control (AQC) Cartridge for use with the RAPIDLab 1200 Series, RAPIDPoint 400 Series and RAPIDPoint 500 Analysers. In vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-2012-RN-01168-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2012-11-21
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 automatic quality control (aqc) cartridge can be difficult to remove from the system and will occasionally post a d33:2 valve error and fail to eject from the instrument. the manufacturer advises that the error is generated only during a failed ejection of the aqc cartridge. the issue appears to coincide with the recent introduction of the new return spring design for the aqc cartridge.
  • 조치
    Siemens is providing work around instructions for users to implement.

Device

  • 모델명 / 제조번호(시리얼번호)
    Automatic Quality Control (AQC) Cartridge for use with the RAPIDLab 1200 Series, RAPIDPoint 400 Series and RAPIDPoint 500 Analysers. In vitro diagnostic medical device (IVD)Siemens Material Number: 10310323Serial Number: 1335866035 to 1350036305ARTG Number: 185171An in vitro diagnostic medical device (IVD)
  • Manufacturer

Manufacturer