Events

ADVIA Centaur Folate Assay 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-00369-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-03-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00369-1
  • 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 one set of customer complaints related to the performance of the advia centaur systems folate assay, kit lots ending in 223. customers observed that the third party controls bio-rad liquichek and bio-rad lyphochek immunoassay plus folate serum controls may give rise to out of range low results with the advia centaur systems folate assay kits.In addition, siemens has confirmed a second set of customer complaints regarding a shift in whole blood patient results for advia centaur systems folate assay kit lots ending in 219 compared to kit lots ending in 222, 224, 225, 226 and 227.
  • 조치
    Siemens is requesting their customers to discard all kit lots ending in 219 and 223 and to notify Siemens of any replacement needs. Kit lots ending in 222, 224, 225, 226, 227 and above can continue to be used as they provide accurate folate results.

Device

ADVIA Centaur Folate Assay
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur Folate AssayLots Numbers Ending In/Expiration Date219 - 25 March, 2014223 - 12 May, 2014ARTG Number: 175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division