IMMULITE® 2000 IMMULITE® 2000 XPi Immunoassay System. An in vitro diagnostic medical device (IVD)Reagent Carousel Temperature Sensor Printed Circuit Board (PCB) 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-2015-RN-00369-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-04-28
  • 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
    Siemens has identified that some systems may have been manufactured with a defective reagent carousel temperature sensor pcb or a defective pcb assembly.The affected temperature sensor boards may cause icing on the reagent carousel casting. if there is icing within the reagent carousel, there is a potential for the reagent carousel to encounter a mechanical jam which will stop the system from processing samples and will generate errors.Siemens has determined that the reagent contents do not freeze when the incorrectly assembled pcb assembly is installed in the reagent carousel assembly. testing shows that the reagent liquid temperature may fall below 4 °c but not to the point when freezing or slush was observed. the reagents are not compromised; therefore, assay performance is not affected.There is not likely to be any risk to health. the system will stop processing samples if a mechanical jam occurs.
  • 조치
    Siemens will inspect all systems for the defect on the next service visit. In the interim users are requested to contact Siemens Technical Support should an Error [465] or [302] occur. This action has been closed-out on 03/03/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    IMMULITE® 2000 IMMULITE® 2000 XPi Immunoassay System. An in vitro diagnostic medical device (IVD)Reagent Carousel Temperature Sensor Printed Circuit Board (PCB) Assembly ARTG number: 174399
  • Manufacturer

Manufacturer