Events

Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. 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-2014-RN-00003-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-01-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00003-1
  • 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
    Siemens has confirmed an overall average positive bias of 23% against the who 2nd irp 75/502 with the immulite systems total ige assays. the immulite total ige controls will not detect this bias. this issue is not expected to impact patient care since the observed bias in values would not impact selection for omalizumab therapy for asthma.
  • 조치
    Siemens is providing laboratories with this information to allow informed clinical decisions when undertaking Total IgE testing. There are currently no unaffected batches available in Australia. A lookback of previously generated results is a the discretion of the laboratory.

Device

Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. An in...
  • 모델명 / 제조번호(시리얼번호)
    Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. An in vitro diagnostic medical device (IVD)Immulite/Immulite 1000 Total IgETest Code: TIECatalogue Number: LKIE1Seimens Material Number: 10380867Lot Number: 326 and aboveImmulite 2000/Immulite 2000 XPi Total IgETest Code: TIECatalogue Number: L2KIE2, L2KIE6Siemens Material Number: 10380873, 10380872Lot Number: 260 and aboveARTG Number: 179719
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division