Events

Siemens ADVIA Chemistry Systems, Amylase 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
    18384
  • 사례 시작날짜
    2015-04-20
  • 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
    Siemens healthcare diagnostics has confirmed that amylase reagent kit lots 304821 and 304816 for use on the advia® 1200, 1650, 1800 and 2400 chemistry systems demonstrate an increased incidence of absorbance flags (u or u accompanied by u). absorbance flags (u) indicate an abnormally high reagent blank absorbance exceeding the reagent blank limit. in some cases with these reagent lots, sample results may also have a sample absorbance (u) flag indicating a high absorbance for the sample that occurs in conjunction with the (u) flag. amylase results can be generated with these flags.
  • 조치
    Manufacturer to issue advice regarding use

Device

Siemens ADVIA Chemistry Systems, Amylase
  • 모델명 / 제조번호(시리얼번호)
    Model: Catalogue Numbers: 07498401 & 03031177, Affected: Lot Numbers: 304821 & 304816, Expiry Apr-2015
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc