Events

ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) 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-01004-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01004-1
  • 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 confirmed increased assay imprecision and a positive bias (increase in index values) in the low end of the assay with the advia centaur systems hbc total (hbct). the increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in false reactive results.The increase in the number of false reactive results may cause additional testing but should not result in the reporting of an increased number of false positive results to physicians. the instructions for use (ifu) recommends that clinical interpretation be made in conjunction with other hbv serological markers.
  • 조치
    Siemens is asking customers to discontinue use and discard the affected kit lots. Customers are advised to review the letter with their Medical Director. This action has been closed-out on 18/04/2017.

Device

ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) Assay
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur/Centaur XP/Centaur CP Systems HBc Total (HBcT) AssayCatalogue Number: 07566733Siemens Material Number (SMN): 10309508Kit lot numbers: 36217064, 36281064, 36449064, 37406064 and 38177064 Expiration Date: February 10, 2015AUST L number: 93126 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division