Events

Phenobarbitol Reagent (used with ADVIA Chemistry System). An in vitro diagnostic medical device (IVD) 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-2012-RN-01179-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01179-1
  • 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
    Internal studies have indicated there is an error which may cause control values and/or patient values to be increased or decreased by as much as 30%.
  • 조치
    Siemens Healthcare is asking customers to discontinue use and dispose the affected stock. A review of previously generated results should be undertaken at the discretion of the Laboratory Director.

Device

Phenobarbitol Reagent (used with ADVIA Chemistry System). An in vitro diagnostic medical device (...
  • 모델명 / 제조번호(시리얼번호)
    Phenobarbitol Reagent (used with ADVIA Chemistry System). An in vitro diagnostic medical device (IVD)Phenobarbitol Reagent (PHNB_2)Catalogue Number: 10377505Lot Numbers: 244574, 256536ARTG Number: 176643An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division