Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An 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-01174-1
  • 사례 위험등급
    Class II
  • 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 manufacturer confirms a positive shift in patient medians of approximately 20% with the igf-1 assay. the manufacturer advises that the performance of kit lots currently in distribution is in alignment with the medians of the reference data range published in instructions for use. additionally, siemens wants to notify customers of an upcoming major supply disruption.
  • 조치
    Laboratories to implement the work-around provided by the sponsor. A review of previously reported results should be considered.

Device

  • 모델명 / 제조번호(시리얼번호)
    Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An in vitro diagnostic medical device (IVD)Immulite / Immulite 1000 XPi IGF-1Catalogue Number: L2KGFSiemens Material Number: 10381448Lot Number: 441-492Immulite 2000 / Immulite 2000 XPi IGF-1Catalogue Number: LKGF1Siemens Material Number: 10381403Lot Number: 315-334ARTG Number: 179720
  • Manufacturer

Manufacturer