Events

ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare Pty Ltd 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-2017-RN-00389-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00389-1
  • 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
    There is confirmation that the advia centaur br (ca 27.29) assay does not dilute linearly when used with multi-diluent 1 kit. when diluted, some samples over-recover the expected neat value by greater than 120%. dilution of samples with results greater than the analytical measuring range for the advia centaur br (ca 27.29) assay may be important for serial measurements during treatment.
  • 조치
    Siemens is requesting users to discontinue dilution of samples using the ADVIA Centaur systems BR (CA 27.29) with Multi-Diluent 1 kit lots ending in 2577 and future lots of Multi-Diluent 1 until further notice. Users are advised to contact their local Siemens Customer Care Centre or their local Siemens technical support representative if they receive any complaints of illness or adverse events associated with the affected products.

Device

ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD) Catalogue Numbers: 02419937 (116734) and 03896216 (116735) respectivelySiemens Material Numbers (SMN): 10333349 and 10334837 respectivelyLots ending in 2577 and all future lotsSystems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CPARTG Number: 175636
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd