Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical devices (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-2015-RN-00520-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-17
  • 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 conductive material of the sample cup holders and microsample inserts, which are used to process samples, do not meet specification for facilitating sample level sensing. when sample level sensing is compromised, sample will not be pipetted and the test or tests ordered for the sample will not be run.
  • 조치
    This issue has been corrected for future lots of sample cup holders and microsample inserts. Siemens is requesting laboratories to cease using the faulty sample cup holders and microsample inserts until unaffected sample receptacles are received.

Device

  • 모델명 / 제조번호(시리얼번호)
    Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical devices (IVD)Sample Cup Holder used on Immulite/Immulite 1000 SystemsSiemens Material Number: 10385360 (Set 1-50)Lot number: 15, 16Microsample Insert used on Immulite 2000 / 2000 Xpi SystemsSiemens Material Number: 10385209 (Set of 15)Lot number: 18, 19, 20ARTG Number: 174399
  • Manufacturer

Manufacturer