Events

Siemens ADVIA Centaur Folate 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens Healthcare Diagnostics Inc 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
    16467
  • 사례 시작날짜
    2014-03-28
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • 원인
    Manufacturer has confirmed two different sets of complaints regarding the advia centaur systems folate asay:, folate lot 223: siemens confirmed one set of customer complaints with the advia centaur systems folate assay, kit lots ending in 223. customers observed that the bio-rad liquichek™ and bio-rad lyphochek™ immunoassay plus folate serum controls may go out of range low with the advia centaur systems folate assay, kit lots ending in 223., folate lot 219 whole blood bias: in addition, siemens has confirmed a second set of customer complaints regarding a shift in whole blood patient results when moving from advia centaur systems folate assay, kit lots ending in 219 to kit lots ending in 222, 224, 225, 226 and/or 227.
  • 조치
    Product to be destroyed

Device

Siemens ADVIA Centaur Folate
  • 모델명 / 제조번호(시리얼번호)
    Model: 10310308 10325366 10331250 and 10340209, Affected: kit lots ending in 219, 222, 223, 224, 225, 226 and 227
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc