Events

ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – Hbs 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-2015-RN-00817-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-08-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00817-1
  • 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 healthcare diagnostics has identified an error on the advia centaur confirmatory card that is included in the advia centaur hbsagii kit lot numbers 55825056, 56167056 and 56244056. the error causes an interpretation of ‘invalid’ and a flag of ‘conf n/a’ when the hbsagii positive control is tested with the hbsagii confirmatory (conf) assay.
  • 조치
    Siemens is advising laboratories that the affected ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT HBsAgII kit lots may only be used to generate HBsAgII screening results, however, an alternate lot or alternate method must be used for reporting confirmed results, if confirmatory testing is required. Siemens can assist laboratories in procuring unaffected stock if they rely on the HBsAgII kit for confirmatory testing. This action has been closed-out on 05/12/2016.

Device

ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – Hbs
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT – HbsAgII AssayCatalogue Number: SMN 10492138Lot Numbers: 55825056, 56167056, 56244056ARTG Number: 239120
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd